K243981
- 510(k) number
- K243981
- Device name
- Hexoskin Medical System (7100-00016)
- Applicant
- Carre Technologies, Inc. CA
- Product code
- DXH — Transmitters And Receivers, Electrocardiograph, Tele
- Decision date
- 2025-11-18
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K243981.pdf
Official FDA record: K243981
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.