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510(k) K191877

FLUOROspeed by Shimadzu Corporation — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2019
Date Received
July 15, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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