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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Fetal Doppler Ultrasound
510(k) Number K905536
Device Name FETAL DOPPLER
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number884.2660
Classification Product Code
MAA  
Date Received12/11/1990
Decision Date 04/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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