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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 K820571
Device Name XENAMATIC SERIES OF XENON REBREATH DEV
Applicant
Diversified P.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diversified P.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1390
Classification Product Code
IYT  
Date Received03/02/1982
Decision Date 03/31/1982
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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