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510(k) K212425

MicroTrend System by Exostat Medical, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2024
Date Received
August 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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