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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, X-Ray
510(k) Number K903012
Device Name AUDIOPRAT ENDOSCOPE
Applicant
S.C.D.P.I. of Florida, Inc.
256 N. Nova Rd., Suite 38
Ormond Beach,  FL  32174
Applicant Contact CLAUDE D BERTHOIN
Correspondent
S.C.D.P.I. of Florida, Inc.
256 N. Nova Rd., Suite 38
Ormond Beach,  FL  32174
Correspondent Contact CLAUDE D BERTHOIN
Regulation Number872.1840
Classification Product Code
EHB  
Date Received07/11/1990
Decision Date 10/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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