AIRLIFE ELECTRONIC INCENTIVE SPIROMETER— 510(k) K851334

Name: FDA 510(k) clearance K851334
Creator: U.S. Food and Drug Administration
Published: 1985-08-06

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K851334 for AIRLIFE ELECTRONIC INCENTIVE SPIROMETER, Substantially Equivalent on 1985-08-06. Applicant: American Pharmaseal Div. Ahsc. Device class: 2.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1985-04-01
Decision date: 1985-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

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