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510(k) K190207

Blood Pressure Monitor by Shenzhen Viatom Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2019
Date Received
February 4, 2019
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 Shenzhen Viatom Technology Co., Ltd.

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  • K193348 — Blood Pressure Monitor (June 25, 2020)
  • K191088 — Checkme O2 Pulse Oximeter (December 2, 2019)

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  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
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