Cleared Traditional

TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)

K122214 · Nihon Kohden Corp. · Anesthesiology
May 2013
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K122214 is an FDA 510(k) clearance for the TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T), 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 May 21, 2013, 300 days after receiving the submission on July 25, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K122214 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2012
Decision Date May 21, 2013
Days to Decision 300 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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