510(k) K242326
K242326 is an FDA 510(k) premarket notification submitted by Bionit Labs Srl for the device "Wave Electrode (AE02-60); Wave Electrode (AE02-50)". The FDA issued a decision of Substantially Equivalent on January 2, 2025. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Bionit Labs Srl has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 2025
- Date Received
- August 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type