SONOSITE MAXX SERIES ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

SONOSITE,INC.

The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Maxx Series Ultrasound System.

Pre-market Notification Details

Device IDK082098
510k NumberK082098
Device Name:SONOSITE MAXX SERIES ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant SONOSITE,INC. 21919 30TH DRIVE SE. Bothell,  WA  98021 -3904
ContactChristopher J Hartzog
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeLLZ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-07-25
Decision Date2008-08-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841517105709 K082098 000
00841517105693 K082098 000

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