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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K842687
Device Name BIOMEDICS BLADDER SCANNER
Applicant
Biomedics
P.O. Box 971
Mercer Island,  WA  98040
Applicant Contact HOWARD M HOCHBERG
Correspondent
Biomedics
P.O. Box 971
Mercer Island,  WA  98040
Correspondent Contact HOWARD M HOCHBERG
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/10/1984
Decision Date 04/08/1985
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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