CADDIE— 510(k) K240044
Substantially EquivalentOdin Medical Limited
FDA 510(k) clearance K240044 for CADDIE, Substantially Equivalent on 2024-07-24. Applicant: Odin Medical Limited. Device class: 2.
Clearance details
- Applicant
- Odin Medical Limited
- Product code
- Code QNP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1520
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, GB
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