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510(k) K201206

Pivot Breath Sensor by Carrot, Inc. — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2021
Date Received
May 4, 2020
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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