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FDA 510(k)

9000 SERIES FILTER & FILTER/HME

K-Number: K963053 · 1997-02-21

ApplicantEnternet Medical, Inc.
Decision Date1997-02-21
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

9000 SERIES FILTER & FILTER/HME is the device name listed in this FDA 510(k) record. The listed applicant is Enternet Medical, Inc.. It received FDA 510(k) clearance on 1997-02-21 under 510(k) number K963053. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 9000 SERIES FILTER & FILTER/HME?

9000 SERIES FILTER & FILTER/HME is a medical device that received FDA 510(k) clearance on 1997-02-21. The listed applicant is Enternet Medical, Inc.. The 510(k) number is K963053.

When did 9000 SERIES FILTER & FILTER/HME receive FDA 510(k) clearance?

9000 SERIES FILTER & FILTER/HME received FDA 510(k) clearance on 1997-02-21, under 510(k) number K963053.

Who is the listed applicant for 9000 SERIES FILTER & FILTER/HME?

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

What is the FDA product code for 9000 SERIES FILTER & FILTER/HME?

The FDA product code for 9000 SERIES FILTER & FILTER/HME is CAH.

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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.

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