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510(k) K083456

NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P by Nihon Kohden America, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2009
Date Received
November 21, 2008
Clearance Type
Special
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

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  • K080342 — NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES (February 26, 2008)
  • K073491 — EEG-1100A SWITCH BOX (January 11, 2008)

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