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FDA 510(k)

AMBUVAC

K-Number: K971548 · 1997-05-22

ApplicantKinetic Concepts, Inc.
Decision Date1997-05-22
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMBUVAC is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K971548. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBUVAC?

AMBUVAC is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K971548.

When did AMBUVAC receive FDA 510(k) clearance?

AMBUVAC received FDA 510(k) clearance on 1997-05-22, under 510(k) number K971548.

Who is the listed applicant for AMBUVAC?

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

What is the FDA product code for AMBUVAC?

The FDA product code for AMBUVAC is OMP.

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Other records listing Kinetic Concepts, Inc. as applicant

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Related Devices (Code: OMP)

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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