510(k) K213930
- Device
- Brainlab Elements Guide XT, Guide 3.0
- Applicant
- Brainlab AG
- 510(k) number
- K213930
- Product code
- QQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-19
- Date received
- 2021-12-16
- 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
- No
Related Records
Applicant Contact
- Contact
- Chiara Cunico
- Address
- Olof-Palme-Str.9 Munich DE 81829 81829
FDA Registration Numbers
- 8043933
- 2182207
- 3018094310