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510(k) K222153

Device
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
Applicant
Microlife Intellectual Property GmbH
510(k) number
K222153
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-03
Date received
2022-07-20
Regulation
870.1130
Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gerhard Frick
Address
Espenstrasse 139 Widnau CH 9443 9443

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)Joytech Healthcare Co. , Ltd.2026-02-13
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K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-01-12