Wave Electrode (AE02-60); Wave Electrode (AE02-50)— 510(k) K242326
Substantially EquivalentBionit Labs Srl
FDA 510(k) clearance K242326 for Wave Electrode (AE02-60); Wave Electrode (AE02-50), Substantially Equivalent on 2025-01-02. Applicant: Bionit Labs Srl. Device class: 2.
Clearance details
- Applicant
- Bionit Labs Srl
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Soleto, IT
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More clearances from Bionit Labs Srl
view allData sourced from openFDA. This site is unofficial and independent of the FDA.