510(k) K230812
K230812 is an FDA 510(k) premarket notification submitted by Withings for the device "Withings Scan Monitor 2.0". The FDA issued a decision of Substantially Equivalent on August 23, 2023. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Withings has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2023
- Date Received
- March 24, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type