FDA 510(k) Premarket Notification K163485: SmartTouch

Submission Details & Decision

Normalized public record details for 510(k) notification K163485.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K163485

Applicant / Sponsor

Adherium (Nz), Ltd.

Device Name

SmartTouch

Product Code

CAF

Decision Date

2017-08-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Traditional

Third Party Flag

Date Received

2016-12-12

Related Establishments / Registrations

VINCENT MEDICAL MANUFACTURING. CO., LTD. Registration: 1000604079 View Registration
MERCURY MEDICAL Registration: 1024404 View Registration
NIDEK MEDICAL PRODUCTS, INC. Registration: 1039215 View Registration
The Ritedose Corporation Registration: 1063407 View Registration
MYLAN PHARMACEUTICALS INC. Registration: 1110315 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
MONAGHAN MEDICAL CORP. Registration: 1317346 View Registration
Medline Industries - Arlington Heights Registration: 1417411 View Registration
Amsino Healthcare (USA) Inc. Registration: 1417519 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
Sterigenics U.S., LLC Registration: 1420032 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Omron Healthcare, Inc. Registration: 1450057 View Registration
ICU Medical, Inc. Registration: 1526863 View Registration
Pulmodyne Inc. Registration: 1832562 View Registration
Bausch & Lomb Incorporated Registration: 1920664 View Registration
Allied Medical LLC Registration: 1924066 View Registration
COVIDIEN Registration: 2024500 View Registration
THAYER MEDICAL CORPORTATION Registration: 2026894 View Registration
WESTMED, INC. Registration: 2028807 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
MEDI NUCLEAR CORP., INC. Registration: 2050098 View Registration
FISHER & PAYKEL HEALTHCARE, INC. Registration: 2085602 View Registration
CREATION TECHNOLOGIES WISCONSIN INC. Registration: 2126519 View Registration
DeVilbiss Healthcare LLC. Registration: 2515872 View Registration
RESPIRONICS INC. Registration: 2518422 View Registration
INSTRUMENTATION INDUSTRIES, INCORPORATED Registration: 2518436 View Registration
MIRION TECHNOLOGIES (CAPINTEC), INC Registration: 2518443 View Registration
CUSTOMED, INC. Registration: 2648727 View Registration
B & B MEDICAL TECHNOLOGIES, INC. Registration: 2938401 View Registration
PARI RESPIRATORY EQUIPMENT, INC. Registration: 2954963 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
POLYGREEN (HK) CO., LTD. Registration: 3001034529 View Registration
UAB INTERSURGICAL Registration: 3001313714 View Registration
OMRON (DALIAN) CO., LTD. (PLANT 1) Registration: 3001373226 View Registration
RESPIRONICS, INC. Registration: 3002797442 View Registration
COGENT TECHNOLOGY LIMITED Registration: 3002806730 View Registration
INTERSURGICAL LTD. Registration: 3002807267 View Registration
AEROGEN LTD Registration: 3003399703 View Registration
BARRINGTON VENTURES, LTD Registration: 3003622639 View Registration
TECNOLOGIAS MEDICAS INNOVADORAS S DE RL Registration: 3003767629 View Registration
ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD Registration: 3003781173 View Registration
EMG TECHNOLOGY CO., LTD. Registration: 3003803075 View Registration
DONGGUAN POLYGREEN TECHNOLOGY CO., LTD. Registration: 3003829675 View Registration
HSINER CO., LTD. Registration: 3003862188 View Registration
LIVING SCIENCE CO., LTD. Registration: 3004022358 View Registration
Hangzhou Jinlin Medical Appliances Co., Ltd. Registration: 3004056932 View Registration
AEROGEN LTD. Registration: 3004127293 View Registration
TAIDOC TECHNOLOGY CORPORATION Registration: 3004145393 View Registration
Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 View Registration
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. Registration: 3004443928 View Registration
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. Registration: 3004727093 View Registration
Salter Labs Registration: 3004748541 View Registration
AMTRION GMBH (formerly Haseke & Kroemker) Registration: 3005285078 View Registration
HANA MICROELECTRONICS PUBLIC CO.,LTD. Registration: 3005321947 View Registration
Laboratorios PISA S.A. de C.V. Registration: 3005440755 View Registration
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Registration: 3005569927 View Registration
Westmed Javid de Mexico, S.A. de C.V. Registration: 3005587132 View Registration
AMSINO MEDICAL (KUNSHAN) CO., LTD. Registration: 3005669815 View Registration
OK BIOTECH CO., LTD. Registration: 3005862821 View Registration
SCIENTIFIC MOLDING CORPORATION, LTD. DBA SMC LTD. Registration: 3005910889 View Registration
SUNMED AP, LTD. Registration: 3005998497 View Registration
FLEXICARE MEDICAL (DONGGUAN) LTD. Registration: 3006061749 View Registration
ASIA CONNECTION CO., LTD. Registration: 3006157842 View Registration
Apex Medical (Kunshan) Corp. Registration: 3006339858 View Registration
SUNSET HEALTHCARE SOLUTIONS, Inc. Registration: 3006446479 View Registration
SMC Medical Manufacturing Private Limited Registration: 3006467300 View Registration
PHARMACARIBE LLC Registration: 3006500694 View Registration
NINGBO BESMED MEDICAL EQUIPMENT CORP. Registration: 3006547005 View Registration
Westmed de Mexico, S.A de C.V Registration: 3006606984 View Registration
GaleMed (Xiamen) Co., Ltd. Registration: 3006783791 View Registration
Omron Healthcare Manufacturing Vietnam Co., Ltd. Registration: 3006852037 View Registration
FORA CARE INC. Registration: 3007134734 View Registration
Mandarin Enterprises, LLC Registration: 3007154442 View Registration
ClensTech Inc.dba ASEPT PAK INC. Registration: 3007177643 View Registration
Flextronics Manufacturing Juarez S. DE R.L. DE C.V. Registration: 3007344957 View Registration
SIMPLE DIAGNOSTICS Registration: 3007384659 View Registration
Laboratorios PiSA, S. A. de C.V. Registration: 3007502289 View Registration
HONSUN (NANTONG) Co., Ltd. Registration: 3007740533 View Registration
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. Registration: 3008220943 View Registration
FOSHAN GAUNYING ELECTRONICS CO., LTD Registration: 3008395118 View Registration
Vectura Group LTD Registration: 3008702754 View Registration
SUMMIT MEDICAL LLC Registration: 3008719017 View Registration
PRODIGY DIABETES CARE, LLC Registration: 3008789114 View Registration
ConvaTec Limited, GDC Building Registration: 3008806809 View Registration
LIFE SCIENCE LOGISTICS, LLC Registration: 3009057691 View Registration
Mankind Pharma Limited Registration: 3009083745 View Registration
MICROBASE TECHNOLOGY CORP. Registration: 3009095356 View Registration
Proactive Medical Products Registration: 3009327812 View Registration
Drive DeVilbiss Healthcare Registration: 3009683397 View Registration
TRINITY MEDICAL DEVICES INC. Registration: 3010042047 View Registration
ADHERIUM (NZ) LTD Registration: 3010047139 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
Globalcare Medical Technology HK, Ltd. Registration: 3010205626 View Registration
Salter Labs de Mexico de S.A. de C.V. Registration: 3010272829 View Registration
SHENZHEN HOMED MEDICAL DEVICE CO LTD Registration: 3010287621 View Registration
FOREMOUNT ENTERPRISE CO., LTD. Registration: 3010402691 View Registration
JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. Registration: 3010594263 View Registration
MEDIUSA INC. Registration: 3010713600 View Registration
Sunset Healthcare Solutions Central Warehouse Registration: 3010834934 View Registration
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD Registration: 3010880718 View Registration
NEPHRON SC, LLC. Registration: 3010892830 View Registration
DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT CO., LTD. Registration: 3011189029 View Registration
VIVE Health LLC Registration: 3011191255 View Registration
MicroVapor Devices, LLC Registration: 3011528328 View Registration
SHENZHEN BI-RICH MEDICAL DEVICES CO., LTD Registration: 3011716786 View Registration
ALC ENTERPRISES INC Registration: 3011721071 View Registration
ConvaTec, Inc. Registration: 3011987967 View Registration
NOVEM MEDICAL S. DE R.L. DE C.V. Registration: 3012187635 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
COMPASS HEALTH BRANDS (CORPORATE OFFICE) Registration: 3012316249 View Registration
ENCHANT TEK CO. LTD. Registration: 3012329712 View Registration
Vapotherm Inc. Registration: 3012971441 View Registration
SHENZHEN HOMED MEDICAL DEVICE CO LTD Registration: 3013000203 View Registration
JOYTECH HEALTHCARE CO.,LTD. Registration: 3013053058 View Registration
FOSHAN HONGFENG CO.,LTD Registration: 3013440654 View Registration
Voluntis Registration: 3013530341 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
O&M Halyard, Inc. Registration: 3014421917 View Registration
Medline International B.V. Registration: 3014499739 View Registration
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD. Registration: 3014866140 View Registration
FEELLIFE HEALTH INC. Registration: 3014916466 View Registration
JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. Registration: 3015058854 View Registration
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3015142935 View Registration
BLUE ECHO CARE Registration: 3015418903 View Registration
Drive DeVilbiss Healthcare Registration: 3015772781 View Registration
FISHER & PAYKEL HEALTHCARE S.A.DE C.V. Registration: 3015928685 View Registration
HONGRITA PRECISION COMPONENT (ZHONG SHAN) LTD. Registration: 3016088544 View Registration
HEALTH & LIFE MEDICAL TECHNOLOGY COMPANY LIMITED Registration: 3016445583 View Registration
SHENZHEN JERMEI MEDICAL DEVICE TECHNOLOGY CO.,LTD Registration: 3016731115 View Registration
HCMED INNOVATIONS CO., LTD. Registration: 3016750005 View Registration
COGNITA LABS LLC Registration: 3017200972 View Registration
SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD Registration: 3017207990 View Registration
LITTLE DOCTOR ELECTRONIC(NANTONG) CO.,LTD Registration: 3017303999 View Registration
FESUN SHANGHAI CO., LTD. Registration: 3017896419 View Registration
SHENZHEN HUAYAN E-COMMERCE CO., LTD. Registration: 3017953405 View Registration
Aerogen Shannon Registration: 3018070843 View Registration
WOODSTOCK STERILE SOLUTIONS, INC. Registration: 3018782623 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration
SHENZHEN IVANKACA TECHNOLOGY CO.,LTD Registration: 3020638914 View Registration
SUNSET HEALTHCARE SOLUTIONS Warehouse Registration: 3021244152 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
Philips Global Business Services LLP Registration: 3029227324 View Registration
RCI HUDSON DE MEXICO S. DE RL. DE CV. Registration: 3029706818 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
JOYTECH HEALTHCARE CO., LTD. Registration: 3030671608 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
CARE LIVING DIAGNOSTICS INC Registration: 3031259044 View Registration
HSINER CO., LTD. Registration: 3031369651 View Registration
Fainteer Limited Registration: 3031506335 View Registration
BEIJING CHOICEMMED TECHNOLOGY CO., LTD. Registration: 3032013079 View Registration
RVA MEDICAL LLC Registration: 3033332986 View Registration
K-JUMP HEALTH CO., LTD. RENDE PLANT Registration: 3033482477 View Registration
WARRENSLOVE(HONGKONG)LIMITED Registration: 3033530347 View Registration
Radnostix Registration: 3034521 View Registration
DUALAMS,INC. DBA AIRKOR(R) Registration: 3034654861 View Registration
Bi-Rich Medical Devices (Cambodia) Co. Ltd Registration: 3036830503 View Registration
Respironics Medical Products (Shenzhen) Co., Ltd. Registration: 3038562397 View Registration
Drive DeVilbiss Healthcare Registration: 3043460907 View Registration
Drive Northpoint, LLC Registration: 3044563261 View Registration
SUNMED AP, LTD., WAREHOUSE NO. 2 Registration: 3044994756 View Registration
FOFO MEDICAL CO.,LTD Registration: 3045077467 View Registration
MAQUET CRITICAL CARE AB Registration: 8010042 View Registration
FLEXICARE MEDICAL LTD. Registration: 8021995 View Registration
SOUTHMEDIC, INC. Registration: 8022032 View Registration
AMG MEDICAL INC. Registration: 8022077 View Registration
VALENTINE INTL. LTD. Registration: 8022890 View Registration
OMRON HEALTHCARE CO., LTD. Registration: 8030245 View Registration
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. Registration: 8030673 View Registration
GALEMED CORP. Registration: 8043316 View Registration
Wellell Inc. Registration: 8043439 View Registration
K-JUMP HEALTH CO., LTD. Registration: 8043510 View Registration
PLAXTRON INDUSTRIAL (M) SDN. BHD. Registration: 8044169 View Registration
O-TWO MEDICAL TECHNOLOGIES, INC. Registration: 9610861 View Registration
OMRON HEALTHCARE Co., Ltd. Matsusaka Factory Registration: 9611045 View Registration
FISHER & PAYKEL HEALTHCARE, LTD. Registration: 9611451 View Registration
TRUDELL MEDICAL INTERNATIONAL Registration: 9612777 View Registration
HEADSTAR MEDICAL PRODUCTS CO., LTD Registration: 9616354 View Registration
Health & Life Corporation Registration: 9616390 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
VEGA TECHNOLOGIES INC. Registration: 9616843 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
NOUVAG AG Registration: 9680741 View Registration
BLS SYSTEMS, LTD. Registration: 9681848 View Registration
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. Registration: 9710391 View Registration
Besmed Health Business Corporation Registration: 9710567 View Registration
WESTMED de Mexico, S.A de C.V. Registration: 9710644 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.