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510(k) K140380

OPERA SWING by General Medical Merate S.P.A — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2014
Date Received
February 14, 2014
Clearance Type
Traditional
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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  • K041605 — PRECISION RXI ANALOG X-RAY SYSTEM (June 30, 2004)
  • K881386 — X-RAY GENERATING SYSTEM TF 1000 (July 8, 1988)
  • K827993 — MTH C/A MOBILE C ARM (September 13, 1982)

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