FDA 510(k)

DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN

K-Number: K970811 · 1998-11-13

Decision Date1998-11-13

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN is the device name listed in this FDA 510(k) record. The listed applicant is Pneumocare, Inc.. It received FDA 510(k) clearance on 1998-11-13 under 510(k) number K970811. 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 DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN?

DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN is a medical device that received FDA 510(k) clearance on 1998-11-13. The listed applicant is Pneumocare, Inc.. The 510(k) number is K970811.

When did DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN receive FDA 510(k) clearance?

DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN received FDA 510(k) clearance on 1998-11-13, under 510(k) number K970811.

Who is the listed applicant for DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN?

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

What is the FDA product code for DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN?

The FDA product code for DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN 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.