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FDA 510(k)

BREATHE-FREE

K-Number: K875073 · 1988-02-29

ApplicantCincinnati Medical Technologies, Inc.
Decision Date1988-02-29
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHE-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Cincinnati Medical Technologies, Inc.. It received FDA 510(k) clearance on 1988-02-29 under 510(k) number K875073. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHE-FREE?

BREATHE-FREE is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Cincinnati Medical Technologies, Inc.. The 510(k) number is K875073.

When did BREATHE-FREE receive FDA 510(k) clearance?

BREATHE-FREE received FDA 510(k) clearance on 1988-02-29, under 510(k) number K875073.

Who is the listed applicant for BREATHE-FREE?

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

What is the FDA product code for BREATHE-FREE?

The FDA product code for BREATHE-FREE is BYE.

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Related Devices (Code: BYE)

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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