THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER— 510(k) K870514

Name: FDA 510(k) clearance K870514
Creator: U.S. Food and Drug Administration
Published: 1987-03-31

Substantially Equivalent

Health Products, Inc.

FDA 510(k) clearance K870514 for THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER, Substantially Equivalent on 1987-03-31. Applicant: Health Products, Inc.. Device class: 2.

Clearance details

Applicant: Health Products, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1987-02-05
Decision date: 1987-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Grove, NJ, US

Download summary PDF View on FDA.gov ↗

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