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FDA 510(k)

PFLEX RESPIRATORY MUSCLE EXERCISER

K-Number: K842634 · 1984-08-10

ApplicantHealth Scan, Inc.
Decision Date1984-08-10
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PFLEX RESPIRATORY MUSCLE EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Health Scan, Inc.. It received FDA 510(k) clearance on 1984-08-10 under 510(k) number K842634. 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 PFLEX RESPIRATORY MUSCLE EXERCISER?

PFLEX RESPIRATORY MUSCLE EXERCISER is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is Health Scan, Inc.. The 510(k) number is K842634.

When did PFLEX RESPIRATORY MUSCLE EXERCISER receive FDA 510(k) clearance?

PFLEX RESPIRATORY MUSCLE EXERCISER received FDA 510(k) clearance on 1984-08-10, under 510(k) number K842634.

Who is the listed applicant for PFLEX RESPIRATORY MUSCLE EXERCISER?

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

What is the FDA product code for PFLEX RESPIRATORY MUSCLE EXERCISER?

The FDA product code for PFLEX RESPIRATORY MUSCLE EXERCISER is BWF.

Related Clinical Trials

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Other records listing Health Scan, 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.

K952909AUTOZONEK820528PFLEX TMK820032VIT-O-METER

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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