FDA 510(k)

BIVONA HYPERFLEX TRACHEOSTOMY TUBE

K-Number: K922665 · 1993-01-07

Decision Date1993-01-07

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA HYPERFLEX TRACHEOSTOMY TUBE 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 1993-01-07 under 510(k) number K922665. 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 HYPERFLEX TRACHEOSTOMY TUBE?

BIVONA HYPERFLEX TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1993-01-07. The listed applicant is Bivona Medical Technologies. The 510(k) number is K922665.

When did BIVONA HYPERFLEX TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

BIVONA HYPERFLEX TRACHEOSTOMY TUBE received FDA 510(k) clearance on 1993-01-07, under 510(k) number K922665.

Who is the listed applicant for BIVONA HYPERFLEX TRACHEOSTOMY TUBE?

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 HYPERFLEX TRACHEOSTOMY TUBE?

The FDA product code for BIVONA HYPERFLEX TRACHEOSTOMY TUBE 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.