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FDA 510(k)

THE BREATHER

K-Number: K944412 · 1995-04-26

ApplicantPal Medical, Inc.
Decision Date1995-04-26
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE BREATHER is the device name listed in this FDA 510(k) record. The listed applicant is Pal Medical, Inc.. It received FDA 510(k) clearance on 1995-04-26 under 510(k) number K944412. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BREATHER?

THE BREATHER is a medical device that received FDA 510(k) clearance on 1995-04-26. The listed applicant is Pal Medical, Inc.. The 510(k) number is K944412.

When did THE BREATHER receive FDA 510(k) clearance?

THE BREATHER received FDA 510(k) clearance on 1995-04-26, under 510(k) number K944412.

Who is the listed applicant for THE BREATHER?

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

What is the FDA product code for THE BREATHER?

The FDA product code for THE BREATHER is BWF.

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Related Devices (Code: BWF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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