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FDA 510(k)

Withings Scan Monitor 2.0

K-Number: K230812 · 2023-08-23

ApplicantWithings
Decision Date2023-08-23
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Withings Scan Monitor 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Withings. It received FDA 510(k) clearance on 2023-08-23 under 510(k) number K230812. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Withings Scan Monitor 2.0?

Withings Scan Monitor 2.0 is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Withings. The 510(k) number is K230812.

When did Withings Scan Monitor 2.0 receive FDA 510(k) clearance?

Withings Scan Monitor 2.0 received FDA 510(k) clearance on 2023-08-23, under 510(k) number K230812.

Who is the listed applicant for Withings Scan Monitor 2.0?

The FDA 510(k) record lists Withings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Withings Scan Monitor 2.0?

The FDA product code for Withings Scan Monitor 2.0 is DPS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06637878SCT02 Clinical Accuracy ValidationCOMPLETEDNCT07595016Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-EclampsiaRECRUITINGNCT07631715Withings Hypertension Notification Retrospective StudyACTIVE_NOT_RECRUITINGNCT07654491Withings HFRN Retrospective StudyNOT_YET_RECRUITING

Other records listing Withings as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252474Withings BeamO (SCT02)K240795Withings ECG AppK231667Withings Sleep RxK201456Scan MonitorK160544Withings Thermo (Model SCT01)

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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