FDA 510(k)

D R Burton OxyPAP

K-Number: K192000 · 2020-02-19

Decision Date2020-02-19

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

D R Burton OxyPAP is the device name listed in this FDA 510(k) record. The listed applicant is D R Burton Healthcare, LLC. It received FDA 510(k) clearance on 2020-02-19 under 510(k) number K192000. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D R Burton OxyPAP?

D R Burton OxyPAP is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is D R Burton Healthcare, LLC. The 510(k) number is K192000.

When did D R Burton OxyPAP receive FDA 510(k) clearance?

D R Burton OxyPAP received FDA 510(k) clearance on 2020-02-19, under 510(k) number K192000.

Who is the listed applicant for D R Burton OxyPAP?

The FDA 510(k) record lists D R Burton Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D R Burton OxyPAP?

The FDA product code for D R Burton OxyPAP is BWF.

Other records listing D R Burton Healthcare, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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