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FDA 510(k)

PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE

K-Number: K961077 · 1996-07-15

ApplicantHealthscan Products, Inc.
Decision Date1996-07-15
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Healthscan Products, Inc.. It received FDA 510(k) clearance on 1996-07-15 under 510(k) number K961077. 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 PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE?

PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is Healthscan Products, Inc.. The 510(k) number is K961077.

When did PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE receive FDA 510(k) clearance?

PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE received FDA 510(k) clearance on 1996-07-15, under 510(k) number K961077.

Who is the listed applicant for PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE?

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

What is the FDA product code for PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE?

The FDA product code for PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE is BWF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Healthscan Products, 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.

K962924PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEMK962929PERSONAL BEST IIK962822OPTICHAMBERK933889PERSONAL BEST LOW RANGE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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