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FDA 510(k)

D R Burton OxyPAP

K-Number: K192000 · 2020-02-19

ApplicantD R Burton Healthcare, LLC
Decision Date2020-02-19
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

D R Burton OxyPAP is a medical device manufactured by D R Burton Healthcare, LLC. It received FDA 510(k) clearance on 2020-02-19 under approval 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. It is manufactured by D R Burton Healthcare, LLC. The 510(k) number is K192000.

When was D R Burton OxyPAP approved by the FDA?

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

What company makes D R Burton OxyPAP?

D R Burton OxyPAP is manufactured by D R Burton Healthcare, LLC.

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

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

Other Devices by D R Burton Healthcare, LLC

K160636iPEP System and vPEP

Related Devices (Code: BWF)

K160636iPEP System and vPEPD R Burton Healthcare, LLC K150044O-PEPPari Respiratory Equipment, Inc. K153441VibraPEPMedica Holdings, LLC K172388VPOD ITPRAdvanced Circulatory System, A Wholly Owned Subsidiary OF K160837MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAMMedinet Srl K163091VibraPEPMedica Holdings, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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