Cleared Traditional

GENIE, MODEL CH-200

K070633 · Icu Medical, Inc. · General Hospital
Jun 2007
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K070633 is an FDA 510(k) clearance for the GENIE, MODEL CH-200, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 5, 2007, 90 days after receiving the submission on March 7, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K070633 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2007
Decision Date June 05, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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