Vivid S60N, Vivid S70N

System, Imaging, Pulsed Doppler, Ultrasonic

GE Medical Systems Ultrasound And Primary Care Diagnostics,

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics, with the FDA for Vivid S60n, Vivid S70n.

Pre-market Notification Details

Device IDK220619
510k NumberK220619
Device Name:Vivid S60N, Vivid S70N
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentLee Bush
GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-03
Decision Date2022-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195278516312 K220619 000
00195278505316 K220619 000
00195278505255 K220619 000
00195278505187 K220619 000
00195278505170 K220619 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.