MyoSPECT, MyoSpect ES

System, Tomography, Computed, Emission

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Myospect, Myospect Es.

Pre-market Notification Details

Device IDK212004
510k NumberK212004
Device Name:MyoSPECT, MyoSpect ES
ClassificationSystem, Tomography, Computed, Emission
Applicant GE Healthcare 4 Hayozma Street Tirat Hacarmel,  IL 30200
ContactGeorge Mashour
CorrespondentGeorge Mashour
GE Healthcare 4 Hayozma Street Tirat Hacarmel,  IL 30200
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-28
Decision Date2021-08-27

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