CardIQ Flow

System, Tomography, Computed, Emission

GE Medical Systems SCS

The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Cardiq Flow.

Pre-market Notification Details

Device IDK192277
510k NumberK192277
Device Name:CardIQ Flow
ClassificationSystem, Tomography, Computed, Emission
Applicant GE Medical Systems SCS 283 Rue De La Miniere Buc,  FR 78530
ContactElizabeth Mathew
CorrespondentElizabeth Mathew
GE Medical Systems SCS 283 Rue De La Miniere Buc,  FR 78530
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-02-14

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