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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 K033156
Device Name OB1 OBSTETRICAL DOPPLER
Applicant
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Applicant Contact D. EUGENE HOKANSON
Correspondent
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Correspondent Contact D. EUGENE HOKANSON
Regulation Number884.2660
Classification Product Code
KNG  
Date Received09/30/2003
Decision Date 12/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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