510(k) K122214

TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) by Nihon Kohden Corp. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2013
Date Received
July 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type