Devices · Withings

Withings Scan Monitor 2.0

Withings is listed for Withings Scan Monitor 2.0 (K230812). The FDA list gives August 23, 2023 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DPS. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230812

Official FDA database record

Date of final decision

August 23, 2023

Company on the FDA list

Withings

Lead panel

Cardiovascular

Primary product code

DPS

openFDA device name for the code

Electrocardiograph

Device class

2

Regulation number

870.2340

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary