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510(k) K123792

HORIZON XVU (FFR) by Mennen Medical , Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2013
Date Received
December 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Mennen Medical , Ltd.

  • K141441 — MENNTOR X7 (January 9, 2015)
  • K131789 — CEREBRALOGIK- AEEG (December 27, 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)
  • K070254 — HORIZON SE (April 19, 2007)

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