Patient Administration Set— 510(k) K200916

Name: FDA 510(k) clearance K200916
Creator: U.S. Food and Drug Administration
Published: 2020-09-01

Substantially Equivalent

Cyclomedica Australia Pty, Ltd.

FDA 510(k) clearance K200916 for Patient Administration Set, Substantially Equivalent on 2020-09-01. Applicant: Cyclomedica Australia Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Cyclomedica Australia Pty, Ltd.
Product code: Code IYT
Device class: Class 2
Regulation: 21 CFR 892.1390
Advisory panel: Radiology
Date received: 2020-04-06
Decision date: 2020-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingsgrove, AU

Download summary PDF View on FDA.gov ↗

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