PFLEX RESPIRATORY MUSCLE EXERCISER— 510(k) K842634

Name: FDA 510(k) clearance K842634
Creator: U.S. Food and Drug Administration
Published: 1984-08-10

Substantially Equivalent

Health Scan, Inc.

FDA 510(k) clearance K842634 for PFLEX RESPIRATORY MUSCLE EXERCISER, Substantially Equivalent on 1984-08-10. Applicant: Health Scan, Inc.. Device class: 2.

Clearance details

Applicant: Health Scan, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1984-07-06
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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