VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION

System, Imaging, Pulsed Echo, Ultrasonic

VOLCANO CORPORATION

The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Lomap,volcano Lomap Option Kit For Mobile System,volcano Lomap Option For Integrated System,volcano S5 Precision.

Pre-market Notification Details

Device IDK133142
510k NumberK133142
Device Name:VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant VOLCANO CORPORATION 1 FORTUNE DR Billerica,  MA  01821
ContactElaine Alan
CorrespondentElaine Alan
VOLCANO CORPORATION 1 FORTUNE DR Billerica,  MA  01821
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2013-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845225001261 K133142 000

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