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FDA 510(k)

BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS

K-Number: K083507 · 2009-05-18

ApplicantAllied Healthcare Products, Inc.
Decision Date2009-05-18
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Allied Healthcare Products, Inc.. It received FDA 510(k) clearance on 2009-05-18 under 510(k) number K083507. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS?

BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS is a medical device that received FDA 510(k) clearance on 2009-05-18. The listed applicant is Allied Healthcare Products, Inc.. The 510(k) number is K083507.

When did BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS receive FDA 510(k) clearance?

BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS received FDA 510(k) clearance on 2009-05-18, under 510(k) number K083507.

Who is the listed applicant for BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS?

The FDA 510(k) record lists Allied Healthcare Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS?

The FDA product code for BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS is BTL.

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Other records listing Allied Healthcare Products, Inc. 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.

K090356EMERGENCY PORTABLE VENTILATOR, MODEL EPV200K083385MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-BK080063MASS CASUALTY VENTILATOR, MODEL MCV100K072214PORTABLE VENTILATOR, MODEL EPV-100K073171RESUSCITATION TIMER, MODEL L770-CPRK070636AUTOVENT 4000 WITH CPAP

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Related Devices (Code: BTL)

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.

K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO KgaaK221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/AK202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KGK182956Puffin Lite Infant Resuscitation SystemInternational BiomedicalK173373SafeT T-Piece ResuscitatorVentlab, LLC

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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