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510(k) K222153

Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) by Microlife Intellectual Property GmbH — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2023
Date Received
July 20, 2022
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

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  • K183663 — Microlife Digital Infrared Ear Thermometer (July 16, 2019)
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