510(k) K232974
K232974 is an FDA 510(k) premarket notification submitted by Ekgenius, LLC for the device "EKGenius Smart System". The FDA issued a decision of Substantially Equivalent on November 17, 2023. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2023
- Date Received
- September 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type