VENTRI 1.1

System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS F.I. HAIFA

The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Ventri 1.1.

Pre-market Notification Details

Device IDK080124
510k NumberK080124
Device Name:VENTRI 1.1
ClassificationSystem, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel,  IL 30200
ContactLaurence Bigio
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-01-17
Decision Date2008-01-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682105286 K080124 000

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