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510(k) K171129

CO Check Pro, CO Screen by MD Diagnostics Limited — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2018
Date Received
April 17, 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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