TM-ABI system
510(k) K143152
TM-ABI system is a Class II device made by Ld Technology, LLC, cleared under FDA 510(k) K143152 on 22 Jul 2015, 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 | NumberK143152 | Date22 Jul 2015 | StatusActive |
Official records
- FDA 510(k) database K143152
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOM
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2780
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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