Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch Bp Office Afib (TWIN200 Afs).

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K101275 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K171937 Active Cleared 16 Mar 2018

• Microlife Wrist Watch Blood Pressure Monitor BP3AX1-4U

  Class II

  FDA 510(k) K061403 Active Cleared 14 Jun 2006

• Microlife Instant Digital Electronic Thermometer, Model QT1JA1

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• Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290

  Class II

  FDA 510(k) K033818 Active Cleared 8 Jan 2004

• Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models Pf-100 and Pf-100-1 (with Software)

  Class II

  FDA 510(k) K040723 Active Cleared 10 Jun 2004

See all devices from Microlife Intellectual Property GmbH →