FDA 510(k)

BIVONA(R) ICU ENDOTRACHEAL TUBE

K-Number: K931749 · 1993-08-10

Decision Date1993-08-10

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA(R) ICU 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 1993-08-10 under 510(k) number K931749. 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(R) ICU ENDOTRACHEAL TUBE?

BIVONA(R) ICU ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1993-08-10. The listed applicant is Bivona Medical Technologies. The 510(k) number is K931749.

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

BIVONA(R) ICU ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1993-08-10, under 510(k) number K931749.

Who is the listed applicant for BIVONA(R) ICU 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(R) ICU ENDOTRACHEAL TUBE?

The FDA product code for BIVONA(R) ICU ENDOTRACHEAL TUBE is BTR.

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Other records listing Bivona Medical Technologies as applicant

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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.