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510(k) K191813

MobileDiagnost wDR 2.2 by Sedecal., Sa. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2019
Date Received
July 5, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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  • K161345 — RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (July 6, 2016)

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