510(k) K024245

ENVOY PATIENT MONITOR by Mennen Medical , Ltd. — Product Code OMC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 10, 2004
Date Received: December 23, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Reduced- Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

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)
K071348 — EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM (September 7, 2007)

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