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510(k) K924879

EP 3000 by Oec-Diasonics, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1993
Date Received
September 28, 1992
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

Other clearances by Oec-Diasonics, Inc.

  • K926056 — 9600 FLUOROSCOPIC IMAGING SYSTEM (January 21, 1993)
  • K914446 — UROVIEW 2000, MODIFICATION (January 10, 1992)
  • K896583 — F.A.S.T. TABLE (March 1, 1990)
  • K893475 — UROVIEW II (August 10, 1989)
  • K872022 — UROVIEW (July 16, 1987)
  • K864837 — MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM (January 30, 1987)
  • K843972 — ANGIOPLUS-S (January 3, 1985)

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