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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, heart sound, fetal, ultrasonic
510(k) Number K883334
Device Name BIODOP(TM)
Applicant
DIAGNOSIS RELATED SYSTEMS, INC.
7760 WEST 20TH AVE., UNIT 11
HIALEAH,  FL  33016
Applicant Contact VICTOR VALDES
Correspondent
DIAGNOSIS RELATED SYSTEMS, INC.
7760 WEST 20TH AVE., UNIT 11
HIALEAH,  FL  33016
Correspondent Contact VICTOR VALDES
Regulation Number884.2660
Classification Product Code
HEK  
Date Received08/09/1988
Decision Date 12/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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