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510(k) K170856

CMS600P2 B-Ultrasound Diagnostic System by Contec Medical Systems Co.,Ltd — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2017
Date Received
March 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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