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FDA 510(k)

DigitalDiagnost

K-Number: K210692 · 2021-04-02

Decision Date2021-04-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DigitalDiagnost is a medical device manufactured by Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2021-04-02 under approval number K210692. 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?

DigitalDiagnost is a medical device that received FDA 510(k) clearance on 2021-04-02. It is manufactured by Philips Medical Systems Dmc GmbH. The 510(k) number is K210692.

When was DigitalDiagnost approved by the FDA?

DigitalDiagnost received FDA 510(k) clearance on 2021-04-02, under approval number K210692.

What company makes DigitalDiagnost?

DigitalDiagnost is manufactured by Philips Medical Systems Dmc GmbH.

What is the FDA product code for DigitalDiagnost?

The FDA product code for DigitalDiagnost is KPR.

Other Devices by Philips Medical Systems Dmc GmbH

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Related Devices (Code: KPR)

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.