DRX-Compass

System, X-ray, Stationary

Carestream Health, Inc

The following data is part of a premarket notification filed by Carestream Health, Inc with the FDA for Drx-compass.

Pre-market Notification Details

Device IDK201373
510k NumberK201373
Device Name:DRX-Compass
ClassificationSystem, X-ray, Stationary
Applicant Carestream Health, Inc Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone,  CN 201206
ContactDuane Gutowski
CorrespondentDuane Gutowski
Carestream Health, Inc Building 7, No. 1510 Chuanqiao Road China (shanghai) Pilot Free Trade Zone,  CN 201206
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-26
Decision Date2020-06-26

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