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510(k) K080342

NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES by Nihon Kohden America, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2008
Date Received
February 8, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Nihon Kohden America, Inc.

  • K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX (March 22, 2012)
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  • K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM (July 9, 2010)
  • K083456 — NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P (March 2, 2009)
  • K083271 — BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SER (December 24, 2008)
  • K082785 — NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES (November 26, 2008)
  • K071969 — SEN-4100 ELECTRIC STIMULATOR (October 6, 2008)
  • K080546 — NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (August 29, 2008)
  • K073550 — PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION (March 28, 2008)
  • K073491 — EEG-1100A SWITCH BOX (January 11, 2008)

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