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510(k) K100225

PULSE OXIMETER MODEL P10 by Mediana Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2011
Date Received
January 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Mediana Co., Ltd.

  • K200434 — V20, V20a, AVSM3 SNF (October 9, 2020)
  • K170497 — V10 (December 15, 2017)
  • K160358 — DT-100 (February 24, 2017)
  • K152659 — V10 (August 25, 2016)
  • K112190 — PATIENT MONITOR (November 9, 2011)
  • K110612 — FM20 (November 8, 2011)
  • K110630 — F10 (June 24, 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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  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)