FDA 510(k) Premarket Notification K123945: STRIVE DUAL ZONE PEAK FLOW METER

Submission Details & Decision

Normalized public record details for 510(k) notification K123945.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K123945

Applicant / Sponsor

Monaghan Medical Corp.

Device Name

STRIVE DUAL ZONE PEAK FLOW METER

Product Code

BZH

Decision Date

2013-04-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Traditional

Third Party Flag

Date Received

2012-12-21

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

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