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FDA 510(k)

HAND-E-BREATH

K-Number: K921339 · 1992-10-01

ApplicantJerry Mccarty
Decision Date1992-10-01
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAND-E-BREATH is the device name listed in this FDA 510(k) record. The listed applicant is Jerry Mccarty. It received FDA 510(k) clearance on 1992-10-01 under 510(k) number K921339. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAND-E-BREATH?

HAND-E-BREATH is a medical device that received FDA 510(k) clearance on 1992-10-01. The listed applicant is Jerry Mccarty. The 510(k) number is K921339.

When did HAND-E-BREATH receive FDA 510(k) clearance?

HAND-E-BREATH received FDA 510(k) clearance on 1992-10-01, under 510(k) number K921339.

Who is the listed applicant for HAND-E-BREATH?

The FDA 510(k) record lists Jerry Mccarty as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAND-E-BREATH?

The FDA product code for HAND-E-BREATH is CAF.

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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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