FDA 510(k) Premarket Notification K050853: PMP4 SPIROPRO

Submission Details & Decision

Normalized public record details for 510(k) notification K050853.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K050853

Applicant / Sponsor

Card Guard Scientific Survival , Ltd.

Device Name

PMP4 SPIROPRO

Product Code

BZH

Decision Date

2005-05-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Special

Third Party Flag

Date Received

2005-04-04

Related Establishments / Registrations

VINCENT MEDICAL MANUFACTURING. CO., LTD. Registration: 1000604079 View Registration
MONAGHAN MEDICAL CORP. Registration: 1317346 View Registration
Omron Healthcare, Inc. Registration: 1450057 View Registration
Anesthesia Associates, Inc. Registration: 2022648 View Registration
RESPIRONICS INC. Registration: 2518422 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
VITALOGRAPH IRELAND LTD. Registration: 3002808458 View Registration
MICROLIFE INTELLECTUAL PROPERTY GMBH Registration: 3003993690 View Registration
VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD. Registration: 3004050971 View Registration
Quest Products, Inc Registration: 3004087544 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
Genia Medical, Inc. Registration: 3004157007 View Registration
SONIC MANUFACTURING TECHNOLOGIES, INC. Registration: 3004541594 View Registration
Salter Labs Registration: 3004748541 View Registration
FORA CARE INC. Registration: 3007134734 View Registration
eResearchTechnology GmbH Registration: 3008505660 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
Salter Labs de Mexico de S.A. de C.V. Registration: 3010272829 View Registration
BiometerPlus USA, Inc. Registration: 3010830834 View Registration
SANICURE BV Registration: 3012494290 View Registration
TAIAN DALU MEDICAL INSTRUMENT CO.,LTD. Registration: 3014335097 View Registration
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD Registration: 3016218294 View Registration
HUMA THERAPEUTICS LIMITED Registration: 3016670256 View Registration
Flexicare Lanka (Pvt) Ltd Registration: 3017202422 View Registration
TENOVI CO Registration: 3017520431 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
Chongqing Sonmol Technology Co., Ltd. Registration: 3021235837 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
AIDAR HEALTH, INC Registration: 3023412068 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
GOSTAR CO., LTD. Registration: 3030626362 View Registration
FONDCIRCLE INC. Registration: 3034603279 View Registration
Respironics Medical Products (Shenzhen) Co., Ltd. Registration: 3038562397 View Registration
MICROLIFE CORP. Registration: 8020605 View Registration
GALEMED CORP. Registration: 8043316 View Registration
CLEMENT CLARKE INTL., LTD. Registration: 9610639 View Registration
TRUDELL MEDICAL INTERNATIONAL Registration: 9612777 View Registration
MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. Registration: 9614860 View Registration
Jaeger Medical GmbH Registration: 9615102 View Registration
ONBO ELECTRONIC (SHENZHEN) CO. LTD. Registration: 9680225 View Registration
Besmed Health Business Corporation Registration: 9710567 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.