FDA 510(k)

BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE

K-Number: K894614 · 1989-10-13

Decision Date1989-10-13

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA AIRE-CUF ADJUSTABLE 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 1989-10-13 under 510(k) number K894614. 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 AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE?

BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Bivona Medical Technologies. The 510(k) number is K894614.

When did BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE receive FDA 510(k) clearance?

BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE received FDA 510(k) clearance on 1989-10-13, under 510(k) number K894614.

Who is the listed applicant for BIVONA AIRE-CUF ADJUSTABLE 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 AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE?

The FDA product code for BIVONA AIRE-CUF ADJUSTABLE 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.