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510(k) K083271

BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY by Nihon Kohden America, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2008
Date Received
November 6, 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

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  • K073550 — PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION (March 28, 2008)
  • K080342 — NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES (February 26, 2008)
  • K073491 — EEG-1100A SWITCH BOX (January 11, 2008)

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