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510(k) K051921

THE EDGE DETECTOR, MODEL 1118 by Sun Nuclear Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2005
Date Received
July 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Sun Nuclear Corp.

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  • K092019 — MODEL 1014 PC ELECTROMETER (September 15, 2009)
  • K063021 — PROFILER 2 (November 22, 2006)
  • K013689 — RE-ENTRANT CHAMBER (July 2, 2002)
  • K021463 — MODEL 1133 IVD PC VERSION (June 6, 2002)
  • K011332 — RF-IVD WIRELESS DOSIMETER-MODEL 1133 (July 26, 2001)
  • K011466 — QED DIODE DETECTORS, MODELS 1112-1116 (June 6, 2001)
  • K010449 — IVD (IN VIVO DOSIMETER), MODEL 1131 (May 4, 2001)
  • K002446 — RE-ENTRANT CHAMBER, MODEL 1008 OR 44D (October 23, 2000)

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