DuraDiagnost
K-Number: K201640 · 2020-07-09
Decision Date2020-07-09
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DuraDiagnost is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-07-09 under approval number K201640. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DuraDiagnost?
DuraDiagnost is a medical device that received FDA 510(k) clearance on 2020-07-09. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K201640.
When was DuraDiagnost approved by the FDA?
DuraDiagnost received FDA 510(k) clearance on 2020-07-09, under approval number K201640.
What company makes DuraDiagnost?
DuraDiagnost is manufactured by Philips Healthcare (Suzhou) Co., Ltd..
What is the FDA product code for DuraDiagnost?
The FDA product code for DuraDiagnost is KPR.
Other Devices by Philips Healthcare (Suzhou) Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.