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FDA 510(k)

DigitalDiagnost C50

K-Number: K201725 · 2020-07-10

ApplicantPhilips Healthcare (Suzhou) Co., Lit.
Decision Date2020-07-10
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DigitalDiagnost C50 is a medical device manufactured by Philips Healthcare (Suzhou) Co., Lit.. It received FDA 510(k) clearance on 2020-07-10 under approval number K201725. 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 DigitalDiagnost C50?

DigitalDiagnost C50 is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Philips Healthcare (Suzhou) Co., Lit.. The 510(k) number is K201725.

When was DigitalDiagnost C50 approved by the FDA?

DigitalDiagnost C50 received FDA 510(k) clearance on 2020-07-10, under approval number K201725.

What company makes DigitalDiagnost C50?

DigitalDiagnost C50 is manufactured by Philips Healthcare (Suzhou) Co., Lit..

What is the FDA product code for DigitalDiagnost C50?

The FDA product code for DigitalDiagnost C50 is KPR.

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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.

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