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510(k) K073550

PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION by Nihon Kohden America, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2008
Date Received
December 18, 2007
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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  • K071969 — SEN-4100 ELECTRIC STIMULATOR (October 6, 2008)
  • K080546 — NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (August 29, 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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