Class Class II

Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (K222153)

K222153 2023-02-03 Traditional
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Description

Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) by Microlife Intellectual Property GmbH, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222153
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeDXN
Regulation Number870.1130

Categories

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Predicate lineage for K222153

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (K222153) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH2020
K112845MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITORMicrolife Intellectual Property GmbH2011
K013434VP-2000/1000Colin Corp.2002

Trace the full predicate network for K222153

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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