Home / 510(k) Clearances / K171937

510(k) K171937

Microlife Upper Arm Automatic Digital Blood Pressure Monitor by Microlife Intellectual Property GmbH — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2018
Date Received
June 28, 2017
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 Microlife Intellectual Property GmbH

  • K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K (June 28, 2023)
  • K222979 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (May 19, 2023)
  • K222153 — Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN20 (February 3, 2023)
  • K211776 — Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) (March 1, 2022)
  • K211288 — Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (November 4, 2021)
  • K202729 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor (April 8, 2021)
  • K200738 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor (July 23, 2020)
  • K200297 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor (June 18, 2020)
  • K191829 — Microlife Non-Contact Infrared Forehead Thermometer (February 13, 2020)
  • K183663 — Microlife Digital Infrared Ear Thermometer (July 16, 2019)

Other clearances for product code DXN

  • K254225 — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH (April 1, 2026)
  • K260276 — Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS (April 1, 2026)
  • K260273 — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B (March 26, 2026)
  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (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)