DigitalDiagnost C50

System, X-ray, Stationary

Philips Healthcare (Suzhou) Co., Lit.

The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Lit. with the FDA for Digitaldiagnost C50.

Pre-market Notification Details

Device IDK201725
510k NumberK201725
Device Name:DigitalDiagnost C50
ClassificationSystem, X-ray, Stationary
Applicant Philips Healthcare (Suzhou) Co., Lit. No. 258, ZhongYuan Road Suzhou Industrial Park Suzhou,  CN 215024
ContactClaire Zhang
CorrespondentClaire Zhang
Philips Healthcare (Suzhou) Co., Lit. No. 258, ZhongYuan Road Suzhou Industrial Park Suzhou,  CN 215024
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-23
Decision Date2020-07-10

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