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510(k) K152659

V10 by Mediana Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2016
Date Received
September 17, 2015
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.

  • K200434 — V20, V20a, AVSM3 SNF (October 9, 2020)
  • K170497 — V10 (December 15, 2017)
  • K160358 — DT-100 (February 24, 2017)
  • 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)
  • K051375 — VITAL SIGNS MONITOR (July 28, 2005)

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  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
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  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)