K232161
- 510(k) number
- K232161
- Device name
- DeepRhythm Platform
- Applicant
- Medicalgorithmics S.A. PL
- Product code
- DPS — Electrocardiograph
- Decision date
- 2024-06-20
- Date received
- 2023-07-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232161.pdf
Official FDA record: K232161
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.