FDA 510(k)

BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES

K-Number: K944178 · 1994-10-27

Decision Date1994-10-27

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES 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 1994-10-27 under 510(k) number K944178. 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 FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES?

BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES is a medical device that received FDA 510(k) clearance on 1994-10-27. The listed applicant is Bivona Medical Technologies. The 510(k) number is K944178.

When did BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES receive FDA 510(k) clearance?

BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES received FDA 510(k) clearance on 1994-10-27, under 510(k) number K944178.

Who is the listed applicant for BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES?

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 FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES?

The FDA product code for BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES is JOH.

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Official Source

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