DuraDiagnost
K-Number: K201640 · 2020-07-09
Device Summary
Frequently Asked Questions
What is the DuraDiagnost?
DuraDiagnost is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K201640.
When did DuraDiagnost receive FDA 510(k) clearance?
DuraDiagnost received FDA 510(k) clearance on 2020-07-09, under 510(k) number K201640.
Who is the listed applicant for DuraDiagnost?
The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DuraDiagnost?
The FDA product code for DuraDiagnost is KPR.
Other records listing Philips Healthcare (Suzhou) Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: KPR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.