SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM

Transducer, Ultrasonic, Diagnostic

SONOSITE,INC.

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

Pre-market Notification Details

Device IDK101757
510k NumberK101757
Device Name:SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant SONOSITE,INC. 21919 30TH DRIVE SE. Bothell,  WA  98021 -3904
ContactMary K Moore
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeITX  
Subsequent Product CodeIYN
Subsequent Product CodeIYO
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-06-23
Decision Date2010-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841517105747 K101757 000
00841517110390 K101757 000
00841517108908 K101757 000
00841517108939 K101757 000
00841517108946 K101757 000
00841517108953 K101757 000
00841517108960 K101757 000
00841517109561 K101757 000
00841517109578 K101757 000
00841517109608 K101757 000
00841517109721 K101757 000
00841517109769 K101757 000
00841517105716 K101757 000
00841517105730 K101757 000
00841517110468 K101757 000

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