Wi-3 HAL-RAR System— 510(k) K150718

Name: FDA 510(k) clearance K150718
Creator: U.S. Food and Drug Administration
Published: 2015-06-12

Substantially Equivalent

Agency For Medical Innovations GmbH

FDA 510(k) clearance K150718 for Wi-3 HAL-RAR System, Substantially Equivalent on 2015-06-12. Applicant: Agency For Medical Innovations GmbH. Device class: 2.

Clearance details

Applicant: Agency For Medical Innovations GmbH
Product code: Code FHN
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2015-03-19
Decision date: 2015-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feldkirch, AT

Download summary PDF View on FDA.gov ↗

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