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510(k) K932848

SIMULIX-MC CT EXTENSION by Oldelft Corp. of America — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1994
Date Received
June 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Oldelft Corp. of America

  • K980296 — OLDELFT DIGIDELCA (April 17, 1998)
  • K973219 — AMBER DU (October 8, 1997)
  • K946128 — SIMULIX-HP (May 12, 1995)
  • K950037 — N 800 HF (February 15, 1995)
  • K923584 — THERAPAX DXT 300 SERIES 3 (January 15, 1993)
  • K914784 — PAPILLION PROCTOSCOPE (June 5, 1992)
  • K912466 — OLDELFT SIMULIX-MC (June 28, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)

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