K232974
- 510(k) number
- K232974
- Device name
- EKGenius Smart System
- Applicant
- Ekgenius, LLC NY · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2023-11-17
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.