510(k) K213930
K213930 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Brainlab Elements Guide XT, Guide 3.0". The FDA issued a decision of Substantially Equivalent on Apr 19, 2022. The device falls under product code QQC (Brain Stimulation Programming Planning Software.), a Class II device regulated under 21 CFR 882.5855. Brainlab AG has 141 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 2022
- Date Received
- Dec 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Brain Stimulation Programming Planning Software.
- Device Class
- Class II
- Regulation Number
- 882.5855
- Review Panel
- NE
- Submission Type
- 510(k)
The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.