510(k) K231276
K231276 is an FDA 510(k) premarket notification submitted by Smartcardia SA for the device "SmartCardia 7L Platform". The FDA issued a decision of Substantially Equivalent on August 30, 2023. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Smartcardia SA has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2023
- Date Received
- May 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type