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510(k) K151080

Nihon Kohden CSM 1901 Bedside Monitor by Nihon Kohden — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2015
Date Received
April 22, 2015
Clearance Type
Traditional
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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  • K110410 — MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) (August 4, 2011)
  • K110376 — PE-210AK SWITCH BOX (July 29, 2011)
  • K102106 — NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION (December 17, 2010)
  • K102376 — NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 (December 7, 2010)

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