XENON XE 127/XE 133 GAS DISPENSER— 510(k) K843640

Name: FDA 510(k) clearance K843640
Creator: U.S. Food and Drug Administration
Published: 1985-01-14

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K843640 for XENON XE 127/XE 133 GAS DISPENSER, Substantially Equivalent on 1985-01-14. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Product code IYT
Device class: Class 2
Regulation: 21 CFR 892.1390
Advisory panel: Radiology
Date received: 1984-09-17
Decision date: 1985-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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