Versana Active

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 Versana Active.

Pre-market Notification Details

Device IDK200998
510k NumberK200998
Device Name:Versana Active
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 Received2020-04-16
Decision Date2020-06-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682147194 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147194 K200998 000
00840682147033 K200998 000
00840682147033 K200998 000

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