510(k) K243520
K243520 is an FDA 510(k) premarket notification submitted by Turing Medical Technologies, Inc. for the device "Bullsai Confirm". The FDA issued a decision of Substantially Equivalent on Mar 28, 2025. The device falls under product code QQC (Brain Stimulation Programming Planning Software.), a Class II device regulated under 21 CFR 882.5855. Turing Medical Technologies, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 28, 2025
- Date Received
- Nov 13, 2024
- 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.