Withings Scan Monitor 2.0
FDA 510(k) K230812 · Withings
510(k) numberK230812
Submission
- Device name
- Withings Scan Monitor 2.0
- Applicant
- Withings
Issy-Les-Moulineaux, FR - Received
- March 24, 2023
- Decision date
- August 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K252474 | Withings BeamO (SCT02)DPS · Traditional | 11/10/2025SE |
| K240795 | Withings ECG AppQDA · Traditional | 06/15/2025SE |
| K231667 | Withings Sleep RxMNR · Traditional | 09/06/2024SE |
| K201456 | Scan MonitorDPS · Traditional | 10/05/2021SE |
| K160544 | Withings Thermo (Model SCT01)FLL · Traditional | 06/17/2016SE |
| K133125 | Withings Blood Presure MonitorDXN · Traditional | 03/24/2014SE |
| K110872 | Withings Blood Pressure MonitorDXN · Traditional | 05/20/2011SE |
Questions and answers
When was Withings Scan Monitor 2.0 cleared by the FDA?
Withings Scan Monitor 2.0 (K230812) received a 510(k) decision of Substantially Equivalent on August 23, 2023, 152 days after the submission was received.
What is the product code of K230812?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.