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510(k) K171408

Carbon Monoxide Breath Sensor System (COBSS) by Carrot Sense, Inc. — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2017
Date Received
May 12, 2017
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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