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510(k) K950264

MAGLIFE by Odam — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1996
Date Received
January 23, 1995
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

  • K972535 — MAGLIFE C (January 13, 1998)
  • 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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