Cleared Traditional

AIR SAFETY HEPA, MODEL 3500

K040712 · Air Safety, Ltd. · Anesthesiology
Jun 2004
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K040712 is an FDA 510(k) clearance for the AIR SAFETY HEPA, MODEL 3500, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Air Safety, Ltd. (Mccordsville, US). The FDA issued a Cleared decision on June 3, 2004, 77 days after receiving the submission on March 18, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K040712 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2004
Decision Date June 03, 2004
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MOD — Accessory To Continuous Ventilator (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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