XPLAN 2.2 WITH THE BODY SYSTEM— 510(k) K013661

Name: FDA 510(k) clearance K013661
Creator: U.S. Food and Drug Administration
Published: 2001-12-03

Substantially Equivalent

Radionics, A Division of Tyco Healthcare Group LP

FDA 510(k) clearance K013661 for XPLAN 2.2 WITH THE BODY SYSTEM, Substantially Equivalent on 2001-12-03. Applicant: Radionics, A Division of Tyco Healthcare Group LP. Device class: 2.

Clearance details

Applicant: Radionics, A Division of Tyco Healthcare Group LP
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2001-11-06
Decision date: 2001-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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