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510(k) K952694

CO BREATH ANALYSIS MODULE & MONOXOL II by Bacharach, Inc. — Product Code CCJ

K952694 is an FDA 510(k) premarket notification submitted by Bacharach, Inc. for the device "CO BREATH ANALYSIS MODULE & MONOXOL II". The FDA issued a decision of Substantially Equivalent on January 29, 1996. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1996
Date Received
June 14, 1995
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

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  • K171408 — Carbon Monoxide Breath Sensor System (COBSS) (September 29, 2017)
  • 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)

FDA data resources