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FDA 510(k)

iPEP System and vPEP

K-Number: K160636 · 2016-08-03

ApplicantD R Burton Healthcare, LLC
Decision Date2016-08-03
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iPEP System and vPEP is a medical device manufactured by D R Burton Healthcare, LLC. It received FDA 510(k) clearance on 2016-08-03 under approval number K160636. 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 iPEP System and vPEP?

iPEP System and vPEP is a medical device that received FDA 510(k) clearance on 2016-08-03. It is manufactured by D R Burton Healthcare, LLC. The 510(k) number is K160636.

When was iPEP System and vPEP approved by the FDA?

iPEP System and vPEP received FDA 510(k) clearance on 2016-08-03, under approval number K160636.

What company makes iPEP System and vPEP?

iPEP System and vPEP is manufactured by D R Burton Healthcare, LLC.

What is the FDA product code for iPEP System and vPEP?

The FDA product code for iPEP System and vPEP is BWF.

Other Devices by D R Burton Healthcare, LLC

K192000D R Burton OxyPAP

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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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