Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Scan Monitor

K-Number: K201456 · 2021-10-05

ApplicantWithings SA
Decision Date2021-10-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Scan Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Withings SA. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K201456. 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 Scan Monitor?

Scan Monitor is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Withings SA. The 510(k) number is K201456.

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

Scan Monitor received FDA 510(k) clearance on 2021-10-05, under 510(k) number K201456.

Who is the listed applicant for Scan Monitor?

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

What is the FDA product code for Scan Monitor?

The FDA product code for Scan Monitor 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 SA 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 RxK230812Withings Scan Monitor 2.0K160544Withings 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.

↑