510(k) K241751
K241751 is an FDA 510(k) premarket notification submitted by Positrigo AG for the device "NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat". The FDA issued a decision of Substantially Equivalent on July 15, 2024. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2024
- Date Received
- June 18, 2024
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type