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510(k) K802206

OMNI SCANNER CT 6000 by Omnimedical — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
September 11, 1980
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 Omnimedical

  • K837378 — OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM (May 18, 1983)
  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812393 — 4001 CT SCANNER (October 13, 1981)
  • K812400 — OMNIMEDICAL QUAD I (October 2, 1981)
  • K790673 — OMNIMEDICAL AUTOMATIC 1001 (May 4, 1979)

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