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FDA 510(k)

VibraPEP

K-Number: K163091 · 2017-02-21

ApplicantMedica Holdings, LLC
Decision Date2017-02-21
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VibraPEP is a medical device manufactured by Medica Holdings, LLC. It received FDA 510(k) clearance on 2017-02-21 under approval number K163091. 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 VibraPEP?

VibraPEP is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Medica Holdings, LLC. The 510(k) number is K163091.

When was VibraPEP approved by the FDA?

VibraPEP received FDA 510(k) clearance on 2017-02-21, under approval number K163091.

What company makes VibraPEP?

VibraPEP is manufactured by Medica Holdings, LLC.

What is the FDA product code for VibraPEP?

The FDA product code for VibraPEP is BWF.

Other Devices by Medica Holdings, LLC

K153441VibraPEP K172956Medicant Mucosal Atomizer

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 K173918VersaPAP Positive Airway Pressure (PAP) DeviceTrudell Medical International

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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