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510(k) K202074

Apache Ultrasound System (Model C62) by Compal Electronics, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2020
Date Received
July 27, 2020
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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