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510(k) K812393

4001 CT SCANNER by Omnimedical — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1981
Date Received
August 20, 1981
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)
  • K812400 — OMNIMEDICAL QUAD I (October 2, 1981)
  • K802206 — OMNI SCANNER CT 6000 (October 23, 1980)
  • K790673 — OMNIMEDICAL AUTOMATIC 1001 (May 4, 1979)

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