HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS— 510(k) K123263

Name: FDA 510(k) clearance K123263
Creator: U.S. Food and Drug Administration
Published: 2013-04-04

Substantially Equivalent

Eckert & Ziegler Bebig GmbH

FDA 510(k) clearance K123263 for HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS, Substantially Equivalent on 2013-04-04. Applicant: Eckert & Ziegler Bebig GmbH. Device class: 2.

Clearance details

Applicant: Eckert & Ziegler Bebig GmbH
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2012-10-18
Decision date: 2013-04-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Veenendaal, NL

Download summary PDF View on FDA.gov ↗

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