EKGenius Smart System
FDA 510(k) clearance K232974 · decided 2023-11-17
Clearance details
- K-number
- K232974
- Device name
- EKGenius Smart System
- Applicant
- Ekgenius, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-09-21
- Decision date
- 2023-11-17
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DPS
- Device class
- 2
- Regulation number
- 870.2340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hempstead, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.