FDA 510(k)

BIVONA SLEEP APNEA TUBE

K-Number: K915799 · 1992-02-03

Decision Date1992-02-03

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA SLEEP APNEA 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 1992-02-03 under 510(k) number K915799. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIVONA SLEEP APNEA TUBE?

BIVONA SLEEP APNEA TUBE is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Bivona Medical Technologies. The 510(k) number is K915799.

When did BIVONA SLEEP APNEA TUBE receive FDA 510(k) clearance?

BIVONA SLEEP APNEA TUBE received FDA 510(k) clearance on 1992-02-03, under 510(k) number K915799.

Who is the listed applicant for BIVONA SLEEP APNEA 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 SLEEP APNEA TUBE?

The FDA product code for BIVONA SLEEP APNEA TUBE is BTR.

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Related Devices (Code: BTR)

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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.