FDA 510(k) Premarket Notification K082966: PB 540 VENTILATOR

Submission Details & Decision

Normalized public record details for 510(k) notification K082966.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K082966

Applicant / Sponsor

Covidien, Formerly Nellcor Puritan Bennett, Inc.

Device Name

PB 540 VENTILATOR

Product Code

CBK

Decision Date

2008-10-31

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Special

Third Party Flag

Date Received

2008-10-06

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
VINCENT MEDICAL MANUFACTURING. CO., LTD. Registration: 1000604079 View Registration
ADVANCED INSTRUMENTATIONS, INC. Registration: 1066270 View Registration
ZOLL Medical Corporation Registration: 1218058 View Registration
BIO-MED DEVICES, INC. Registration: 1218704 View Registration
RESPIRONICS NOVAMETRIX, LLC Registration: 1219324 View Registration
ZOLL MEDICAL CORPORATION Registration: 1220908 View Registration
SLEEPNET CORPORATION Registration: 1222088 View Registration
NextPhase Medical Devices LLC Registration: 1225492 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
WELCH ALLYN, INC. Registration: 1316463 View Registration
INTERNATIONAL BIOMEDICAL, LTD. Registration: 1625392 View Registration
Salaera, LLC d.b.a Maxtec Registration: 1722070 View Registration
HANS RUDOLPH, INC. Registration: 1922553 View Registration
Allied Medical LLC Registration: 1924066 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
SECHRIST INDUSTRIES, INC. Registration: 2020676 View Registration
ZOLL Palm Springs Registration: 2021710 View Registration
COVIDIEN Registration: 2024500 View Registration
FISHER & PAYKEL HEALTHCARE, INC. Registration: 2085602 View Registration
ZOLL Medical Corporation Registration: 2112020 View Registration
Datex-Ohmeda, Inc. Registration: 2112667 View Registration
TreyMed, Inc. Registration: 2134715 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
RESPIRONICS INC. Registration: 2518422 View Registration
INSTRUMENTATION INDUSTRIES, INCORPORATED Registration: 2518436 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD. Registration: 3000143502 View Registration
DRAEGERWERK AG & CO. KGAA Registration: 3001104093 View Registration
Respironics Deutschland GmbH & Co.KG Registration: 3001400310 View Registration
HAMILTON MEDICAL AG Registration: 3001421318 View Registration
RESPIRONICS, INC. Registration: 3002797442 View Registration
FLIGHT MEDICAL INNOVATIONS LTD. Registration: 3003135857 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
AIRON CORPORATION Registration: 3003697063 View Registration
HSINER CO., LTD. Registration: 3003862188 View Registration
VENTURE CORPORATION LIMITED Registration: 3003908598 View Registration
VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD. Registration: 3004050971 View Registration
GVS Filter Technology UK Ltd Registration: 3004428458 View Registration
RESMED PTY LTD. Registration: 3004604967 View Registration
Salter Labs Registration: 3004748541 View Registration
DRAEGER MEDICAL SYSTEMS, INC. Registration: 3005783425 View Registration
WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. Registration: 3006087789 View Registration
EVENT MEDICAL, LTD. Registration: 3006135941 View Registration
Creative Foam Corporation dba MT. OLIVE MFG Registration: 3006240053 View Registration
SUNSET HEALTHCARE SOLUTIONS, Inc. Registration: 3006446479 View Registration
GaleMed (Xiamen) Co., Ltd. Registration: 3006783791 View Registration
USR ELECTRONIC SYSTEMS (1987) LTD Registration: 3006807694 View Registration
BEIJING AEONMED CO., LTD. Registration: 3007238566 View Registration
Flextronics Manufacturing Juarez S. DE R.L. DE C.V. Registration: 3007344957 View Registration
TECHNOCOM SYSTEMS SDN BHD Registration: 3007549157 View Registration
RESMED CORP Registration: 3007573469 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
Synergy Health Radeberg GMBH Registration: 3008102042 View Registration
Fisher & Paykel Healthcare S.A.de C.V. Registration: 3008264065 View Registration
Volcano Corporation Registration: 3008363989 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
GPE MedTech Systeme GmbH Registration: 3008867836 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
PPC MOULDING SERVICES PTY LTD Registration: 3009107628 View Registration
Oricare Inc. Registration: 3009129579 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
Tecme SA Registration: 3009302812 View Registration
Volcano Corporation by Volcarica S.R.L. Registration: 3009490946 View Registration
Sanmina Corporation Registration: 3009609218 View Registration
MAQUET CARDIOPULMONARY MEDIKAL TEKNIK SAN. TIC.LTD. STI. Registration: 3010017366 View Registration
ORIGIN MEDICAL DEVICES INC Registration: 3010088563 View Registration
Spacelabs Healthcare Inc. Registration: 3010157426 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
TRIBALCO Registration: 3010317211 View Registration
BREAS MEDICAL, INC. Registration: 3010817335 View Registration
Sunset Healthcare Solutions Central Warehouse Registration: 3010834934 View Registration
NextPhase Medical Devices Mexico LLC Registration: 3010882708 View Registration
REDSTONE HEALTHCARE LLC Registration: 3010952312 View Registration
Plexus Electronica S. de R.L. de C.V.. Registration: 3011120183 View Registration
Tecme Corporation Registration: 3011190789 View Registration
ResMed Corp Registration: 3011205710 View Registration
INOVYTEC MEDICAL SOLUTIONS LTD. Registration: 3011213495 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
HMC Premedical S.p.A. Registration: 3012667060 View Registration
MEDICREATIONS LLC Registration: 3012772112 View Registration
VENTEC LIFE SYSTEMS, INC. Registration: 3013095415 View Registration
Inventus Power, Inc. Registration: 3013154126 View Registration
VYAIRE MEDICAL, INC. Registration: 3013421741 View Registration
NIHON KOHDEN ORANGEMED, LLC Registration: 3014631252 View Registration
Hamilton Medical AG Registration: 3014766741 View Registration
Thora Tech GmbH Registration: 3016450067 View Registration
Philips North America LLC Registration: 3016618143 View Registration
HAMILTON MEDICAL, INC. Registration: 3016723884 View Registration
VENTEC LIFE SYSTEMS, INC. Registration: 3017520736 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
MEHOW INNOVATIVE (HUIZHOU) LTD. Registration: 3020283264 View Registration
SUNSET HEALTHCARE SOLUTIONS Warehouse Registration: 3021244152 View Registration
Ventis Medical Inc Registration: 3021607937 View Registration
Telesair, Inc. Registration: 3021947238 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
LUNG ASSIST II INC Registration: 3025936435 View Registration
TD SYNNEX Registration: 3026740087 View Registration
Philips Global Business Services LLP Registration: 3029227324 View Registration
PERCUSSIONAIRE CORP. Registration: 3029845 View Registration
ZOLL International Holding B.V. Registration: 3029871637 View Registration
Hamilton Medical AG Registration: 3029906224 View Registration
ORIGIN MEDICAL DEVICES HUNGARY KFT Registration: 3029922922 View Registration
INT'AIR MEDICAL Registration: 3030149975 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
HSINER CO., LTD. Registration: 3031369651 View Registration
Philips India Limited - Sleep & Respiratory Care Business Unit Registration: 3033526676 View Registration
CORVENT MEDICAL INC. Registration: 3033571078 View Registration
ZOLL MEDICAL CORPORATION Registration: 3038259592 View Registration
Respironics Medical Products (Shenzhen) Co., Ltd. Registration: 3038562397 View Registration
DSV CONTRACT LOGISTICS Registration: 3044156918 View Registration
MAQUET CRITICAL CARE AB Registration: 8010042 View Registration
VBM MEDIZINTECHNIK GMBH Registration: 8010939 View Registration
Covidien Registration: 8020893 View Registration
COSMED S.R.L. Registration: 8021084 View Registration
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. Registration: 8030673 View Registration
NOLATO MEDITOR AB Registration: 8030941 View Registration
PENLON LTD. Registration: 9610531 View Registration
Covidien Registration: 9610849 View Registration
SPACELABS HEALTHCARE LTD. Registration: 9611295 View Registration
FISHER & PAYKEL HEALTHCARE, LTD. Registration: 9611451 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
WILAMED GMBH Registration: 9615827 View Registration
BREAS MEDICAL AB Registration: 9617566 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
Mallinckrodt Dar S.r.l. Registration: 9680661 View Registration
Covidien Registration: 9681384 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 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.