510(k) K242737
K242737 is an FDA 510(k) premarket notification submitted by Empatica S.r.l. for the device "Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal". The FDA issued a decision of Substantially Equivalent on June 6, 2025. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Empatica S.r.l. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2025
- Date Received
- September 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type