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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Rebreathing, Radionuclide
510(k) Number K843640
Device Name XENON XE 127/XE 133 GAS DISPENSER
Applicant
Mallinckrodt Critical Care
P.O. Box 5840
St. Louis,  MO  63134
Applicant Contact THOMAS W TUSING
Correspondent
Mallinckrodt Critical Care
P.O. Box 5840
St. Louis,  MO  63134
Correspondent Contact Katie Merkel
Regulation Number892.1390
Classification Product Code
IYT  
Date Received09/17/1984
Decision Date 01/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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