FDA 510(k)

ENDOTRACHEAL TUBES, LONG & SHORT TERM

K-Number: K791046 · 1979-06-13

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1979-06-13

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ENDOTRACHEAL TUBES, LONG & SHORT TERM is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1979-06-13 under 510(k) number K791046. 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 ENDOTRACHEAL TUBES, LONG & SHORT TERM?

ENDOTRACHEAL TUBES, LONG & SHORT TERM is a medical device that received FDA 510(k) clearance on 1979-06-13. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K791046.

When did ENDOTRACHEAL TUBES, LONG & SHORT TERM receive FDA 510(k) clearance?

ENDOTRACHEAL TUBES, LONG & SHORT TERM received FDA 510(k) clearance on 1979-06-13, under 510(k) number K791046.

Who is the listed applicant for ENDOTRACHEAL TUBES, LONG & SHORT TERM?

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

What is the FDA product code for ENDOTRACHEAL TUBES, LONG & SHORT TERM?

The FDA product code for ENDOTRACHEAL TUBES, LONG & SHORT TERM is BTR.

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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.