GE QUASAR NUCLEAR MEDICINE SYSTEM

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 Ge Quasar Nuclear Medicine System.

Pre-market Notification Details

Device IDK022960
510k NumberK022960
Device Name:GE QUASAR NUCLEAR MEDICINE SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant GE MEDICAL SYSTEMS F.I. HAIFA 10 HAYOZMA ST. Tirat Hacarmel,  IL 30200
ContactHemy Neuman
CorrespondentHeinz Joerg Steneberg
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-09-06
Decision Date2002-09-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.