Cleared Traditional

AIRGENT, MODEL AG7000010

K082138 · Perfaction, Inc. · General Hospital
Jan 2009
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K082138 is an FDA 510(k) clearance for the AIRGENT, MODEL AG7000010, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by Perfaction, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on January 23, 2009, 178 days after receiving the submission on July 29, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K082138 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2008
Decision Date January 23, 2009
Days to Decision 178 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZE — Injector, Fluid, Non-electrically Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5430

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