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510(k) K071348

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM by Mennen Medical , Ltd. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2007
Date Received
May 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Mennen Medical , Ltd.

  • K141441 — MENNTOR X7 (January 9, 2015)
  • 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)
  • K070254 — HORIZON SE (April 19, 2007)

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