FDA 510(k) Premarket Notification K051628: INFINITY MONITORS WITH SCIO MODIFICATIONS

Submission Details & Decision

Normalized public record details for 510(k) notification K051628.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K051628

Applicant / Sponsor

Draeger Medical Systems, Inc.

Device Name

INFINITY MONITORS WITH SCIO MODIFICATIONS

Product Code

MHX

Decision Date

2005-07-20

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Special

Third Party Flag

Date Received

2005-06-20

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
Polimeros Formula de Tecate S.A de C.V Registration: 1000484830 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
ADVANCED INSTRUMENTATIONS, INC. Registration: 1066270 View Registration
Philips North America LLC Registration: 1218950 View Registration
RESPIRONICS NOVAMETRIX, LLC Registration: 1219324 View Registration
WELCH ALLYN, INC. Registration: 1316463 View Registration
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Registration: 1651104 View Registration
KATECHO LLC Registration: 1930027 View Registration
Nihon Kohden Digital Health Solutions, LLC. Registration: 2032233 View Registration
NIHON KOHDEN AMERICA, INC. Registration: 2080783 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
OBS Medical Ltd Registration: 3000162901 View Registration
DRAEGERWERK AG & CO. KGAA Registration: 3001104093 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3001570235 View Registration
PULSION MEDICAL SYSTEMS SE Registration: 3003263092 View Registration
Flextronics Manufacturing (Singapore) Pte Ltd Registration: 3003589956 View Registration
MEDIANA CO., LTD. Registration: 3003591740 View Registration
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. Registration: 3003832357 View Registration
EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
BERND RICHTER GMBH Registration: 3004035727 View Registration
HIDALGO LIMITED Registration: 3004196561 View Registration
Industrial Vallera de Mexicali, S. A. de C. V. Registration: 3004415095 View Registration
GE HEALTHCARE Registration: 3004526608 View Registration
SUPERCOMAL MEDICAL PRODUCTS, SDN BHD Registration: 3004832480 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
ANYBATTERY, INC Registration: 3005521864 View Registration
DRAEGER MEDICAL SYSTEMS, INC. Registration: 3005783425 View Registration
METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. Registration: 3005906887 View Registration
WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. Registration: 3006087789 View Registration
GENERAL MEDITECH, INC. Registration: 3006147705 View Registration
Sanmina-SCI Systems Singapore Pte. Ltd. Registration: 3006606827 View Registration
CONTEC MEDICAL SYSTEMS CO., LTD Registration: 3006979678 View Registration
MEDEIA GROUP LTD Registration: 3007048291 View Registration
GUANGDONG BIOLIGHT MEDITECH CO., LTD Registration: 3007305624 View Registration
ATHENA GTX Registration: 3007413079 View Registration
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center Registration: 3007481893 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
HOSMED INC. Registration: 3007836437 View Registration
Kimball Electronics Poland Sp.z o.o Registration: 3008058135 View Registration
HI-TECH PRODUCTS DE MEXICO S.A. DE C.V. Registration: 3008255748 View Registration
Volcano Corporation Registration: 3008363989 View Registration
Technical Services for Electronics, Inc. Registration: 3008483389 View Registration
ZOLL Manufacturing Corporation Registration: 3008642652 View Registration
SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. Registration: 3008716327 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
VectraCor, Inc. Registration: 3009443693 View Registration
Volcano Corporation by Volcarica S.R.L. Registration: 3009490946 View Registration
EDAN Diagnostics, Inc. Registration: 3009499478 View Registration
FUKUDA DENSHI CO., LTD. Registration: 3009607734 View Registration
SOTERA WIRELESS Registration: 3009673645 View Registration
AliveCor Registration: 3009715978 View Registration
MASIMO CORPORATION Registration: 3009831876 View Registration
Engineered Medical Systems, LLC Registration: 3009973336 View Registration
Spacelabs Healthcare Inc. Registration: 3010157426 View Registration
MEDISONO, LLC Registration: 3010390468 View Registration
MEDEIA INC Registration: 3010536822 View Registration
LifeSignals, Inc. Registration: 3010552191 View Registration
Natus Neurology Incorporated Registration: 3010611950 View Registration
GWW Registration: 3010698831 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
NextPhase Medical Devices Mexico LLC Registration: 3010882708 View Registration
Plexus Electronica S. de R.L. de C.V.. Registration: 3011120183 View Registration
MASIMO CORPORATION Registration: 3011353843 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
CRITICARE TECHNOLOGIES, INC. Registration: 3012238587 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3012359877 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
Philips North America LLC Registration: 3012528160 View Registration
Defibtech Branford Registration: 3012972516 View Registration
PACETECH Registration: 3013314298 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Registration: 3013501110 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
Repair Operations Center Registration: 3013679558 View Registration
Hypertec HCM LLC Registration: 3013896610 View Registration
ITEK Registration: 3014263632 View Registration
Philips Medical Systems Ltda Registration: 3014541700 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
SUMIDA ELECTRIC (THAILAND) CO.,LTD Registration: 3014633893 View Registration
DREAMTECH CO., LTD. Registration: 3014848734 View Registration
Murata Vios, Private Limited Registration: 3015181391 View Registration
Murata Vios, Inc. Registration: 3015328411 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration
Philips North America LLC Registration: 3016618143 View Registration
Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Registration: 3016674095 View Registration
Philips North America LLC Registration: 3016701404 View Registration
Nihon Kohden Corporation - Eastern Japan Logistics Center Registration: 3016852448 View Registration
JPEX MEDICAL EQUIPMENT & SUPPLIES, INC. Registration: 3016931915 View Registration
LifeSignals India Private Limited Registration: 3017446092 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
Masimo Corporation Registration: 3019388613 View Registration
PARKS MEDICAL ELECTRONICS, INC. Registration: 3020115 View Registration
NIMBLEHEART, INC. Registration: 3021219789 View Registration
CAF MEDICAL SOLUTIONS INC Registration: 3021559257 View Registration
Nihon Vinyl Cord Corporation - Kodama Second Factory Registration: 3021736577 View Registration
VitalConnect, Inc. Registration: 3022123357 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
Nihon Vinyl Cord Corporation - Shimo-ongata Factory Registration: 3030516450 View Registration
HADLEIGH HEALTH TECHNOLOGIES Registration: 3030597679 View Registration
FUKUDA DENSHI USA, INC. Registration: 3031158 View Registration
WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED Registration: 3032109181 View Registration
DREAMTECH VIETNAM CO., LTD Registration: 3043479346 View Registration
CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
NIHON KOHDEN TOMIOKA PRODUCTION CENTER Registration: 8030229 View Registration
SCHILLER AG Registration: 8030978 View Registration
GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
FUKUDA DENSHI CO., LTD. Registration: 9611031 View Registration
NIHON KOHDEN CORP. Registration: 9611252 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
Nicolay GMBH Registration: 9681377 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.