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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 K871868
Device Name VENTI-SCAN II
Applicant
Atomic Products Corp.
P.O. Drawer R
Shirley,  NY  11967
Applicant Contact JAMES REISS
Correspondent
Atomic Products Corp.
P.O. Drawer R
Shirley,  NY  11967
Correspondent Contact JAMES REISS
Regulation Number892.1390
Classification Product Code
IYT  
Date Received05/13/1987
Decision Date 04/11/1988
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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