SITE-RITE VISION II ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, 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 Vision Ii Ultrasound System.

Pre-market Notification Details

Device IDK132942
510k NumberK132942
Device Name:SITE-RITE VISION II ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, 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 CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-19
Decision Date2013-10-17
Summary:summary

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