MODEL U-1000 ULTRASONIC SCANNER

Imager, Ultrasonic Obstetric-gynecologic

FUKUDA DENSHI USA, INC.

The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Model U-1000 Ultrasonic Scanner.

Pre-market Notification Details

Device IDK851902
510k NumberK851902
Device Name:MODEL U-1000 ULTRASONIC SCANNER
ClassificationImager, Ultrasonic Obstetric-gynecologic
Applicant FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland ,  WA  98034 -
ContactDon Andresen
CorrespondentDon Andresen
FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland ,  WA  98034 -
Product CodeHEM  
CFR Regulation Number884.2225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-30
Decision Date1985-09-27

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