AIR SAFETY HEPA, MODEL 3500— 510(k) K040712

Substantially Equivalent

Air Safety, Ltd.

FDA 510(k) clearance K040712 for AIR SAFETY HEPA, MODEL 3500, Substantially Equivalent on 2004-06-03. Applicant: Air Safety, Ltd.. Device class: 2.

Clearance details

Applicant: Air Safety, Ltd.
Product code: Code MOD
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2004-03-18
Decision date: 2004-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, 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.