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510(k) K001888

UNICORN MODEL SYS0630 by Danish Diagnostic Development A/S — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2000
Date Received
June 15, 2000
Clearance Type
Abbreviated
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

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  • K031825 — C.CAM (June 20, 2003)
  • K011611 — CARDIOCAM MODEL 9CSY0799 (June 8, 2001)

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