Limbus Contour— 510(k) K241837
Substantially EquivalentLimbus Ai, Inc.
FDA 510(k) clearance K241837 for Limbus Contour, Substantially Equivalent on 2024-10-09. Applicant: Limbus Ai, Inc.. Device class: 2.
Clearance details
- Applicant
- Limbus Ai, Inc.
- Product code
- Code QKB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Regina, CA
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