510(k) DEN210003
- Device
- SureTune4 Software
- Applicant
- Medtronic Neuromodulation
- 510(k) number
- DEN210003
- Product code
- QQC
- Decision
- Unknown (DENG)
- Decision date
- 2021-08-23
- Date received
- 2021-02-03
- Regulation
- 882.5855
- Classification name
- Brain Stimulation Programming Planning Software.
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Teal Bjoraker
- Address
- 7000 Central Ave., NE Minneapolis MN US 55432 55432
FDA Registration Numbers#
- 8043933
- 3018094310
- 2182207
Source Documents#
510(k) summary PDF not indicated by FDA