FDA 510(k)

BIVONA ILLUMINATED ENDOTRACHEAL TUBE

K-Number: K933398 · 1993-10-06

Decision Date1993-10-06

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA ILLUMINATED ENDOTRACHEAL 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 1993-10-06 under 510(k) number K933398. 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 ILLUMINATED ENDOTRACHEAL TUBE?

BIVONA ILLUMINATED ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1993-10-06. The listed applicant is Bivona Medical Technologies. The 510(k) number is K933398.

When did BIVONA ILLUMINATED ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

BIVONA ILLUMINATED ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1993-10-06, under 510(k) number K933398.

Who is the listed applicant for BIVONA ILLUMINATED ENDOTRACHEAL 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 ILLUMINATED ENDOTRACHEAL TUBE?

The FDA product code for BIVONA ILLUMINATED ENDOTRACHEAL 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.