FDA 510(k)

SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE

K-Number: K925615 · 1993-03-26

ApplicantSorin Biomedica, Fiat, USA, Inc.

Decision Date1993-03-26

Product CodeCBI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1993-03-26 under 510(k) number K925615. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE?

SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE is a medical device that received FDA 510(k) clearance on 1993-03-26. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K925615.

When did SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE receive FDA 510(k) clearance?

SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE received FDA 510(k) clearance on 1993-03-26, under 510(k) number K925615.

Who is the listed applicant for SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE?

The FDA product code for SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE is CBI.

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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.