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FDA 510(k)

O-PEP

K-Number: K150044 · 2016-05-27

ApplicantPari Respiratory Equipment, Inc.
Decision Date2016-05-27
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

O-PEP is a medical device manufactured by Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2016-05-27 under approval number K150044. 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 O-PEP?

O-PEP is a medical device that received FDA 510(k) clearance on 2016-05-27. It is manufactured by Pari Respiratory Equipment, Inc.. The 510(k) number is K150044.

When was O-PEP approved by the FDA?

O-PEP received FDA 510(k) clearance on 2016-05-27, under approval number K150044.

What company makes O-PEP?

O-PEP is manufactured by Pari Respiratory Equipment, Inc..

What is the FDA product code for O-PEP?

The FDA product code for O-PEP is BWF.

Other Devices by Pari Respiratory Equipment, Inc.

K162785Velox Nebulizer System K191270Proneb Max K223840eRapid Nebulizer System K251572eRapid with eTrack System

Related Devices (Code: BWF)

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