THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER— 510(k) K972824

Name: FDA 510(k) clearance K972824
Creator: U.S. Food and Drug Administration
Published: 1998-04-03

Substantially Equivalent

Pn Medical

FDA 510(k) clearance K972824 for THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER, Substantially Equivalent on 1998-04-03. Applicant: Pn Medical. Device class: 2.

Clearance details

Applicant: Pn Medical
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1997-07-30
Decision date: 1998-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

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