Aerobika OPEP Devive with Manometer— 510(k) K150173

Name: FDA 510(k) clearance K150173
Creator: U.S. Food and Drug Administration
Published: 2015-10-15

Substantially Equivalent

Trudell Medical International

FDA 510(k) clearance K150173 for Aerobika OPEP Devive with Manometer, Substantially Equivalent on 2015-10-15. Applicant: Trudell Medical International. Device class: 2.

Clearance details

Applicant: Trudell Medical International
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2015-01-26
Decision date: 2015-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: London, CA

Download summary PDF View on FDA.gov ↗

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