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510(k) K080278

TABATABA COTESTER by Fim Medical — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2008
Date Received
February 4, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1430
Review Panel
AN
Submission Type

Other clearances by Fim Medical

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  • K010761 — SPL-50 SPIROLYSER (March 5, 2002)

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  • K151107 — CoSense ETCO Monitor (July 22, 2015)
  • K130036 — COSENSE CO MONITOR (January 14, 2014)
  • K121768 — COSENSE (October 31, 2012)
  • K082315 — EC50 MICRO+ SMOKERLYZER (February 1, 2010)
  • K070259 — EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (February 21, 2008)