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510(k) K023798

MODIFICATION TO ENVOY PATIENT MONITOR by Mennen Medical , Ltd. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2002
Date Received
November 14, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Mennen Medical , Ltd.

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  • K131789 — CEREBRALOGIK- AEEG (December 27, 2013)
  • K123792 — HORIZON XVU (FFR) (August 30, 2013)
  • K093766 — VITALOGIK 6000/6500 (May 7, 2010)
  • K091165 — HORIZON XVU (August 7, 2009)
  • K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (December 16, 2008)
  • K081484 — HORIZON XVU (June 20, 2008)
  • K073140 — VITALOGIK MODEL 4000/4500 (November 21, 2007)
  • K071899 — BIS MODULE FOR ENVOY PATIENT MONITOR (October 22, 2007)
  • K071348 — EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM (September 7, 2007)

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