OB1 OBSTETRICAL DOPPLER

Monitor, Ultrasonic, Fetal

D. E. HOKANSON, INC.

The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for Ob1 Obstetrical Doppler.

Pre-market Notification Details

Device IDK033156
510k NumberK033156
Device Name:OB1 OBSTETRICAL DOPPLER
ClassificationMonitor, Ultrasonic, Fetal
Applicant D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue,  WA  98005 -1910
ContactD. Eugene Hokanson
CorrespondentD. Eugene Hokanson
D. E. HOKANSON, INC. 12840 N.E. 21ST PL. Bellevue,  WA  98005 -1910
Product CodeKNG  
CFR Regulation Number884.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-30
Decision Date2003-12-09
Summary:summary

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