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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, ultrasonic, fetal
510(k) Number K911453
Device Name OBTRASOUND STETHOSCOPE FETAL CALC
Applicant
MEDASONICS, INC.
47233 FREMONT BLVD.
P.O. BOX 4903
FREMONT,  CA  94538
Applicant Contact KEITH V ROHRBACH
Correspondent
MEDASONICS, INC.
47233 FREMONT BLVD.
P.O. BOX 4903
FREMONT,  CA  94538
Correspondent Contact KEITH V ROHRBACH
Regulation Number884.2660
Classification Product Code
KNG  
Date Received04/03/1991
Decision Date 06/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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