510(k) K202713

TrueView 100 Pro by Compai Healthcare (Shenzhen) Co.,Ltd — Product Code MWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2020
Date Received
September 16, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type