K233755
- 510(k) number
- K233755
- Device name
- HeartKey® Rhythm
- Applicant
- B-Secur Limited GB
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-08-16
- Date received
- 2023-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233755.pdf
Official FDA record: K233755
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.