CAIs Sensor (CAIs-001)— 510(k) K241160
Substantially EquivalentBrainu Co., Ltd.
FDA 510(k) clearance K241160 for CAIs Sensor (CAIs-001), Substantially Equivalent on 2024-12-13. Applicant: Brainu Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Brainu Co., Ltd.
- 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
- Seongnam-Si, KR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.