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510(k) K141441

MENNTOR X7 by Mennen Medical , Ltd. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2015
Date Received
June 2, 2014
Clearance Type
Traditional
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

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  • 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)
  • K070254 — HORIZON SE (April 19, 2007)

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