510(k) K261471
- Device
- Zeta TMS Navigation System
- Applicant
- Zeta Surgical, Inc.
- 510(k) number
- K261471
- Product code
- QFF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-09
- Date received
- 2026-05-04
- Regulation
- 882.5805
- Classification name
- Electromechanical Arm For A Transcranial Magnetic Stimulation System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hieu Le Mau
- Address
- 280 Summer St. Floor 7 Boston MA US 02210 02210
FDA Registration Numbers#
- 3007147067
- 3030130442
- 3022310762
- 3014805507
Source Documents#
Other 510(k) Records For Product Code QFF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182768 | TMS-Cobot TS MV | Axilum Robotics | 2019-02-17 |