DuraDiagnost

System, X-ray, Stationary

Philips Healthcare (Suzhou) Co., Ltd.

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

Pre-market Notification Details

Device IDK201640
510k NumberK201640
Device Name:DuraDiagnost
ClassificationSystem, X-ray, Stationary
Applicant Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou,  CN 215024
ContactMary Zhu
CorrespondentMary Zhu
Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou,  CN 215024
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2020-07-09

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