AIR INCENTIVE SPIROMETER— 510(k) K791819

Substantially Equivalent

Airlife, Inc.

FDA 510(k) clearance K791819 for AIR INCENTIVE SPIROMETER, Substantially Equivalent on 1979-09-26. Applicant: Airlife, Inc.. Device class: 2.

Clearance details

Applicant: Airlife, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1979-09-14
Decision date: 1979-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.