Bladder AI (AIBV01)— 510(k) K230497
Substantially EquivalentExo, Inc.
FDA 510(k) clearance K230497 for Bladder AI (AIBV01), Substantially Equivalent on 2023-06-22. Applicant: Exo, Inc.. Device class: 2.
Clearance details
- Applicant
- Exo, Inc.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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