FDA 510(k)

FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED

K-Number: K972385 · 1998-01-20

ApplicantSmiths Industries Medical Systems, Inc.

Decision Date1998-01-20

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Industries Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-01-20 under 510(k) number K972385. 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 FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED?

FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED is a medical device that received FDA 510(k) clearance on 1998-01-20. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K972385.

When did FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED receive FDA 510(k) clearance?

FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED received FDA 510(k) clearance on 1998-01-20, under 510(k) number K972385.

Who is the listed applicant for FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED?

The FDA 510(k) record lists Smiths Industries Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED?

The FDA product code for FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED is JOH.

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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.