K251218
- 510(k) number
- K251218
- Device name
- SafeBeat Rx App
- Applicant
- SafeBeat Rx, Inc. CA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-02-06
- Date received
- 2025-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K251218.pdf
Official FDA record: K251218
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.