Cleared Traditional

GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS

K110594 · Nihon Kohden Corp. · Anesthesiology
Oct 2011
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K110594 is an FDA 510(k) clearance for the GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on October 28, 2011, 240 days after receiving the submission on March 2, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K110594 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2011
Decision Date October 28, 2011
Days to Decision 240 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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