K230457
- 510(k) number
- K230457
- Device name
- Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
- Applicant
- Empatica S.r.l. IT
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2023-10-30
- Date received
- 2023-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K230457.pdf
Official FDA record: K230457
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.