EVA5 Insufflator— 510(k) K230474
Substantially EquivalentPalliare , Ltd.
FDA 510(k) clearance K230474 for EVA5 Insufflator, Substantially Equivalent on 2023-03-24. Applicant: Palliare , Ltd.. Device class: 2.
Clearance details
- Applicant
- Palliare , Ltd.
- Product code
- Code FCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
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