510(k) K243520
- Device
- Bullsai Confirm
- Applicant
- Turing Medical Technologies, Inc.
- 510(k) number
- K243520
- Product code
- QQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-28
- Date received
- 2024-11-13
- Regulation
- 882.5855
- Classification name
- Brain Stimulation Programming Planning Software.
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christa Nova
- Address
- 393 N Euclid Ave. Suite 310 St. Louis MO US 63108 63108
FDA Registration Numbers#
- 8043933
- 3018094310
- 2182207