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FDA 510(k)

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

K-Number: K032386 · 2004-03-26

ApplicantImpact Instrumentation, Inc.
Decision Date2004-03-26
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Impact Instrumentation, Inc.. It received FDA 510(k) clearance on 2004-03-26 under 510(k) number K032386. 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 UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)?

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) is a medical device that received FDA 510(k) clearance on 2004-03-26. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K032386.

When did UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) receive FDA 510(k) clearance?

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) received FDA 510(k) clearance on 2004-03-26, under 510(k) number K032386.

Who is the listed applicant for UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)?

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

What is the FDA product code for UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)?

The FDA product code for UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) is BTL.

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Other records listing Impact Instrumentation, 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.

K111473UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATORK103318UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATORK091238UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+K071526UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMVK051476UNI-VENT MODEL 73XK022062IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

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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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