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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Radiographic Film/Cassette
510(k) Number K920196
Device Name OX-600
Applicant
Stardard X-Ray Sales Co.
60 Coit St.
Irvington,  NJ  07111
Applicant Contact MARTIN WEINBERG
Correspondent
Stardard X-Ray Sales Co.
60 Coit St.
Irvington,  NJ  07111
Correspondent Contact MARTIN WEINBERG
Regulation Number892.1860
Classification Product Code
KPX  
Date Received01/15/1992
Decision Date 10/14/1992
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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