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510(k) K250136

Globalcare Blood Pressure Monitor (GUS610) by Globalcare Medical Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2025
Date Received
January 17, 2025
Clearance Type
Special
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 Globalcare Medical Technology Co., Ltd.

  • K253896 — TENS/EMS device (GUSE01) (March 4, 2026)
  • K222160 — GUS610 Blood pressure monitor (November 22, 2022)
  • K192633 — GUS831 Compressor Nebulizer (May 1, 2020)
  • K192609 — Globalcare Blood Pressure Monitor (April 21, 2020)

Other clearances for product code DXN

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  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)
  • 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)