510(k) K223027
K223027 is an FDA 510(k) premarket notification submitted by Neurotrigger for the device "NeuroTrigger Basic (NTB)". The FDA issued a decision of Substantially Equivalent on October 10, 2023. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2023
- Date Received
- September 29, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type