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FDA 510(k)

PARI PEP THERAPY SYSTEM

K-Number: K972042 · 1997-08-05

ApplicantPari Holding Co.
Decision Date1997-08-05
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PARI PEP THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pari Holding Co.. It received FDA 510(k) clearance on 1997-08-05 under 510(k) number K972042. 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 PARI PEP THERAPY SYSTEM?

PARI PEP THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-05. The listed applicant is Pari Holding Co.. The 510(k) number is K972042.

When did PARI PEP THERAPY SYSTEM receive FDA 510(k) clearance?

PARI PEP THERAPY SYSTEM received FDA 510(k) clearance on 1997-08-05, under 510(k) number K972042.

Who is the listed applicant for PARI PEP THERAPY SYSTEM?

The FDA 510(k) record lists Pari Holding Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARI PEP THERAPY SYSTEM?

The FDA product code for PARI PEP THERAPY SYSTEM is BWF.

Related Clinical Trials

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Other records listing Pari Holding Co. 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.

K002862PRONEB ULTRA MODEL NUMBER 85B0100K983308RC CORNET, MODEL #44F50K963924LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70K962072PRONEB TURBO COMPRESSOR MODEL 38V0200K960675WALKHALER PORTABLE COMPRESSOR MODEL 45F70K935540PARI-MASTER MODIFICATION

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Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson 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.

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