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510(k) K212515

MOVIX DReamy by Stephanix — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2021
Date Received
August 10, 2021
Clearance Type
Abbreviated
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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