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510(k) K972535

MAGLIFE C by Odam — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1998
Date Received
July 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Odam

  • K950264 — MAGLIFE (September 27, 1996)
  • K854175 — DEFIGARD 2000 (January 13, 1986)
  • K823934 — CARIEL F12 (December 16, 1983)
  • K823933 — MINIDEF (OR DEFIPORT (April 12, 1983)
  • K823931 — DEFIGARD M(OR DEFISCOPE M (April 12, 1983)

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