510(k) K232210
K232210 is an FDA 510(k) premarket notification submitted by X-Trodes for the device "X-trodes System M". The FDA issued a decision of Substantially Equivalent on Feb 4, 2024. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 4, 2024
- Date Received
- Jul 26, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type