SmartCardia 7L Platform
510(k) K231276
SmartCardia 7L Platform is a Class II device made by SmartCardia SA, cleared under FDA 510(k) K231276 on 30 Aug 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231276 | Date30 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K231276
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSI
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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