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510(k) K011611

CARDIOCAM MODEL 9CSY0799 by Danish Diagnostic Development A/S — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2001
Date Received
May 25, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Danish Diagnostic Development A/S

  • K081829 — CAPIMAGE (July 11, 2008)
  • K051460 — C.CAM-AC (June 15, 2005)
  • K040616 — CARDIOMD-AC (March 24, 2004)
  • K031825 — C.CAM (June 20, 2003)
  • K001888 — UNICORN MODEL SYS0630 (June 30, 2000)

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