MEDRAD® Imaging Bulk Package Transfer Set— 510(k) K173913

Name: FDA 510(k) clearance K173913
Creator: U.S. Food and Drug Administration
Published: 2018-05-04

Substantially Equivalent

Bayer U.S., LLC

FDA 510(k) clearance K173913 for MEDRAD® Imaging Bulk Package Transfer Set, Substantially Equivalent on 2018-05-04. Applicant: Bayer U.S., LLC. Device class: 2.

Clearance details

Applicant: Bayer U.S., LLC
Product code: Code PQH
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2017-12-22
Decision date: 2018-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianaola, PA, US

Download summary PDF View on FDA.gov ↗

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