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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K862616
Device Name AMBER-CHEST
Applicant
Old Delft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Applicant Contact DE BRUIN
Correspondent
Old Delft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Correspondent Contact DE BRUIN
Regulation Number892.1680
Classification Product Code
KPR  
Date Received07/09/1986
Decision Date 09/02/1986
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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