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510(k) K864837

MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM by Oec-Diasonics, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1987
Date Received
December 9, 1986
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)
  • K924879 — EP 3000 (January 4, 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)
  • K843972 — ANGIOPLUS-S (January 3, 1985)

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