RectalPro 75 Endorectal Balloon— 510(k) K180478

Name: FDA 510(k) clearance K180478
Creator: U.S. Food and Drug Administration
Published: 2018-11-13

Substantially Equivalent

Qlrad International , Ltd.

FDA 510(k) clearance K180478 for RectalPro 75 Endorectal Balloon, Substantially Equivalent on 2018-11-13. Applicant: Qlrad International , Ltd.. Device class: 2.

Clearance details

Applicant: Qlrad International , Ltd.
Product code: Code PCT
Device class: Class 2
Regulation: 21 CFR 892.5720
Advisory panel: Radiology
Date received: 2018-02-22
Decision date: 2018-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Almere, NL

Download summary PDF View on FDA.gov ↗

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