CSMC Cardiac Suite

System, Tomography, Computed, Emission

Cedars-Sinai Medical Center

The following data is part of a premarket notification filed by Cedars-sinai Medical Center with the FDA for Csmc Cardiac Suite.

Pre-market Notification Details

Device IDK172609
510k NumberK172609
Device Name:CSMC Cardiac Suite
ClassificationSystem, Tomography, Computed, Emission
Applicant Cedars-Sinai Medical Center 8700 Beverly Blvd Los Angeles,  CA  90048
ContactGeoff Pollard
CorrespondentGeoff Pollard
Cedars-Sinai Medical Center 8700 Beverly Blvd Los Angeles,  CA  90048
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-31
Decision Date2017-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00864687000247 K172609 000

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