The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Z-touch.
| Device ID | K003268 |
| 510k Number | K003268 |
| Device Name: | Z-TOUCH |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB, AG 100 MARINE PKWY. SUITE 305 Redwood City, CA 94065 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-18 |
| Decision Date | 2001-02-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() Z-TOUCH 86659163 not registered Dead/Abandoned |
NextInput Inc. 2015-06-11 |
![]() Z-TOUCH 78031509 2781796 Live/Registered |
BrainLAB AG 2000-10-19 |