Home / 510(k) Clearances / K837378

510(k) K837378

OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM by Omnimedical

K837378 is an FDA 510(k) premarket notification submitted by Omnimedical for the device "OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 1983. Omnimedical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1983
Date Received
March 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Omnimedical

  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812393 — 4001 CT SCANNER (October 13, 1981)
  • K812400 — OMNIMEDICAL QUAD I (October 2, 1981)
  • K802206 — OMNI SCANNER CT 6000 (October 23, 1980)
  • K790673 — OMNIMEDICAL AUTOMATIC 1001 (May 4, 1979)

FDA data resources