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FDA 510(k)

EMERGENCY PORTABLE VENTILATOR, MODEL EPV200

K-Number: K090356 · 2009-05-20

ApplicantAllied Healthcare Products, Inc.
Decision Date2009-05-20
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 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 2009-05-20 under 510(k) number K090356. 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 EMERGENCY PORTABLE VENTILATOR, MODEL EPV200?

EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 is a medical device that received FDA 510(k) clearance on 2009-05-20. The listed applicant is Allied Healthcare Products, Inc.. The 510(k) number is K090356.

When did EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 receive FDA 510(k) clearance?

EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 received FDA 510(k) clearance on 2009-05-20, under 510(k) number K090356.

Who is the listed applicant for EMERGENCY PORTABLE VENTILATOR, MODEL EPV200?

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 EMERGENCY PORTABLE VENTILATOR, MODEL EPV200?

The FDA product code for EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 is BTL.

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Other records listing Allied Healthcare Products, Inc. as applicant

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K083507BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORSK083385MASS 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.

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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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