Cleared Traditional

AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM

K912651 · Stackhouse Assoc. · General Hospital
Jul 1991
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K912651 is an FDA 510(k) clearance for the AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Stackhouse Assoc. (Riverside, US). The FDA issued a Cleared decision on July 8, 1991, 21 days after receiving the submission on June 17, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K912651 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1991
Decision Date July 08, 1991
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FYD — Apparatus, Exhaust, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5070

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