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510(k) K112190

PATIENT MONITOR by Mediana Co., Ltd. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2011
Date Received
July 29, 2011
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

Other clearances by Mediana Co., Ltd.

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  • K110612 — FM20 (November 8, 2011)
  • K110630 — F10 (June 24, 2011)
  • K100225 — PULSE OXIMETER MODEL P10 (February 9, 2011)
  • K100217 — LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 (June 8, 2010)
  • K051375 — VITAL SIGNS MONITOR (July 28, 2005)

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