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510(k) K233955

Clarius OB AI by Clarius Mobile Health Corp. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2024
Date Received
December 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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