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510(k) K823934

CARIEL F12 by Odam — Product Code DYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1983
Date Received
December 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vectorcardiograph
Device Class
Class II
Regulation Number
870.2400
Review Panel
CV
Submission Type

Other clearances by Odam

  • K972535 — MAGLIFE C (January 13, 1998)
  • K950264 — MAGLIFE (September 27, 1996)
  • K854175 — DEFIGARD 2000 (January 13, 1986)
  • K823933 — MINIDEF (OR DEFIPORT (April 12, 1983)
  • K823931 — DEFIGARD M(OR DEFISCOPE M (April 12, 1983)

Other clearances for product code DYC

  • K023414 — MIDA ALGORITHM REV. B (December 5, 2003)
  • K896396 — MIDA SYSTEM, MODELS 1000/1100 (January 18, 1990)
  • K810529 — DIRECT WRITING VECTORCARDIOGRAPH (April 23, 1981)