Site-Rite 6 Ultrasound System With Pinpoint GT Technology

System, Imaging, Pulsed Echo, Ultrasonic

C.R. Bard, Inc

The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Site-rite 6 Ultrasound System With Pinpoint Gt Technology.

Pre-market Notification Details

Device IDK142443
510k NumberK142443
Device Name:Site-Rite 6 Ultrasound System With Pinpoint GT Technology
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant C.R. Bard, Inc 605 North 5600 West Salt Lake City,  UT  84116
ContactKerrie Hamblin
CorrespondentKerrie Hamblin
C.R. Bard, Inc 605 North 5600 West Salt Lake City,  UT  84116
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2014-10-30
Summary:summary

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