Z-Touch
by Brainlab AG
510(k) K003268
Z-Touch is a Class II device made by Brainlab AG, cleared under FDA 510(k) K003268 on 22 Feb 2001, 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 | NumberK003268 | Date22 Feb 2001 | StatusActive |
Official records
- FDA 510(k) database K003268
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HAW
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent