K232035
- 510(k) number
- K232035
- Device name
- Impala
- Applicant
- AliveCor, Inc. CA · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2024-06-07
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232035.pdf
Official FDA record: K232035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.