GE VIVID 7 BT04

System, Imaging, Pulsed Doppler, Ultrasonic

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Vivid 7 Bt04.

Pre-market Notification Details

Device IDK041552
510k NumberK041552
Device Name:GE VIVID 7 BT04
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GENERAL ELECTRIC CO. 4855 WEST ELECTRIC AVENUE PO BOX 414 Milwaukee,  WI  53219
ContactAllen Schuh
CorrespondentAllen Schuh
GENERAL ELECTRIC CO. 4855 WEST ELECTRIC AVENUE PO BOX 414 Milwaukee,  WI  53219
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-09
Decision Date2004-07-02
Summary:summary

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