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FDA 510(k)

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310

K-Number: K092029 · 2010-08-06

ApplicantDraeger Medical AG & Co. KG
Decision Date2010-08-06
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical AG & Co. KG. It received FDA 510(k) clearance on 2010-08-06 under 510(k) number K092029. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310?

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Draeger Medical AG & Co. KG. The 510(k) number is K092029.

When did VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 receive FDA 510(k) clearance?

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 received FDA 510(k) clearance on 2010-08-06, under 510(k) number K092029.

Who is the listed applicant for VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310?

The FDA 510(k) record lists Draeger Medical AG & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310?

The FDA product code for VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 is BYE.

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Other records listing Draeger Medical AG & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102618VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATEDK100941INFINITY MCABLE - MAINSTREAM CO2K092999NBP CUFFK083050EVITE XLK081447FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLOK081743CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS

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Related Devices (Code: BYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K090710MERCURY CPAPMercury Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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