X-PORTE ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

FUJIFILM SONOSITE,INC.

The following data is part of a premarket notification filed by Fujifilm Sonosite,inc. with the FDA for X-porte Ultrasound System.

Pre-market Notification Details

Device IDK133134
510k NumberK133134
Device Name:X-PORTE ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant FUJIFILM SONOSITE,INC. 21919 30th Dr SE Bothell,  WA  98021
ContactScott Paulson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo,  MN  55313
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-10-01
Decision Date2013-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841517104740 K133134 000
00841517104733 K133134 000
00841517104436 K133134 000
00841517104412 K133134 000
00841517106423 K133134 000
00841517106416 K133134 000
00841517106409 K133134 000
00841517106393 K133134 000

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