D R Burton OxyPAP— 510(k) K192000

Substantially Equivalent

D R Burton Healthcare, LLC

FDA 510(k) clearance K192000 for D R Burton OxyPAP, Substantially Equivalent on 2020-02-19. Applicant: D R Burton Healthcare, LLC. Device class: 2.

Clearance details

Applicant: D R Burton Healthcare, LLC
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2019-07-26
Decision date: 2020-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmville, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.