FDA 510(k)

iPEP System and vPEP

K-Number: K160636 · 2016-08-03

Decision Date2016-08-03

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

iPEP System and vPEP 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 2016-08-03 under 510(k) 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. The listed applicant is D R Burton Healthcare, LLC. The 510(k) number is K160636.

When did iPEP System and vPEP receive FDA 510(k) clearance?

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

Who is the listed applicant for iPEP System and vPEP?

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 iPEP System and vPEP?

The FDA product code for iPEP System and vPEP 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.

K192000D R Burton OxyPAP

Related Devices (Code: BWF)

K241152InSeeTidal Medical Technologies, LLC K233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLC K222018Breathe+Peep Medical, LLC Dba Go2 Devices K220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.

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.