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FDA 510(k)

MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B

K-Number: K083385 · 2009-05-14

ApplicantAllied Healthcare Products, Inc.
Decision Date2009-05-14
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B 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 2009-05-14 under 510(k) number K083385. 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 MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B?

MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B is a medical device that received FDA 510(k) clearance on 2009-05-14. The listed applicant is Allied Healthcare Products, Inc.. The 510(k) number is K083385.

When did MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B receive FDA 510(k) clearance?

MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B received FDA 510(k) clearance on 2009-05-14, under 510(k) number K083385.

Who is the listed applicant for MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B?

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 MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B?

The FDA product code for MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B is BTL.

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Other records listing Allied Healthcare Products, Inc. as applicant

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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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