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510(k) K180799

Clarius Ultrasound Scanner by Clarius Mobile Health Corp. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2018
Date Received
March 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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