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 IDK182450
510k NumberK182450
Device Name:Vivid S60N, Vivid S70N
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics, 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE Medical Systems Ultrasound And Primary Care Diagnostics, 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 Received2018-09-07
Decision Date2018-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682143936 K182450 000
00840682142885 K182450 000
00840682142861 K182450 000
00840682141680 K182450 000
00840682141666 K182450 000

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