FDA 510(k)

BIVONA CUSTOMIZED TRACHEOSTOMY TUBES

K-Number: K923878 · 1992-12-29

Decision Date1992-12-29

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA CUSTOMIZED TRACHEOSTOMY TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1992-12-29 under 510(k) number K923878. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIVONA CUSTOMIZED TRACHEOSTOMY TUBES?

BIVONA CUSTOMIZED TRACHEOSTOMY TUBES is a medical device that received FDA 510(k) clearance on 1992-12-29. The listed applicant is Bivona Medical Technologies. The 510(k) number is K923878.

When did BIVONA CUSTOMIZED TRACHEOSTOMY TUBES receive FDA 510(k) clearance?

BIVONA CUSTOMIZED TRACHEOSTOMY TUBES received FDA 510(k) clearance on 1992-12-29, under 510(k) number K923878.

Who is the listed applicant for BIVONA CUSTOMIZED TRACHEOSTOMY TUBES?

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

What is the FDA product code for BIVONA CUSTOMIZED TRACHEOSTOMY TUBES?

The FDA product code for BIVONA CUSTOMIZED TRACHEOSTOMY TUBES is JOH.

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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.