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510(k) K051375

VITAL SIGNS MONITOR by Mediana Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2005
Date Received
May 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Mediana Co., Ltd.

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  • K152659 — V10 (August 25, 2016)
  • K112190 — PATIENT MONITOR (November 9, 2011)
  • 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)

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