EVA5 Insufflator— 510(k) K230474

Substantially Equivalent

Palliare , Ltd.

FDA 510(k) clearance K230474 for EVA5 Insufflator, Substantially Equivalent on 2023-03-24. Applicant: Palliare , Ltd..

Clearance details

Applicant: Palliare , Ltd.
Product code: Code FCX
Advisory panel: Gastroenterology, Urology
Date received: 2023-02-22
Decision date: 2023-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

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