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 the device name listed in this FDA 510(k) record. The listed applicant is Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) 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. The listed applicant is Pari Respiratory Equipment, Inc.. The 510(k) number is K150044.

When did O-PEP receive FDA 510(k) clearance?

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

Who is the listed applicant for O-PEP?

The FDA 510(k) record lists Pari Respiratory Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O-PEP?

The FDA product code for O-PEP is BWF.

Other records listing Pari Respiratory Equipment, Inc. 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.

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

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.