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FDA 510(k)

THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER

K-Number: K972824 · 1998-04-03

ApplicantPn Medical
Decision Date1998-04-03
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Pn Medical. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K972824. 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 THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER?

THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Pn Medical. The 510(k) number is K972824.

When did THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER receive FDA 510(k) clearance?

THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER received FDA 510(k) clearance on 1998-04-03, under 510(k) number K972824.

Who is the listed applicant for THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER?

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

What is the FDA product code for THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER?

The FDA product code for THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER is BWF.

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Related Devices (Code: BWF)

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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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