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FDA 510(k)

EchoNavigator R4.0

K-Number: K221270 · 2022-05-31

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2022-05-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoNavigator R4.0 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2022-05-31 under approval number K221270. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoNavigator R4.0?

EchoNavigator R4.0 is a medical device that received FDA 510(k) clearance on 2022-05-31. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K221270.

When was EchoNavigator R4.0 approved by the FDA?

EchoNavigator R4.0 received FDA 510(k) clearance on 2022-05-31, under approval number K221270.

What company makes EchoNavigator R4.0?

EchoNavigator R4.0 is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for EchoNavigator R4.0?

The FDA product code for EchoNavigator R4.0 is LLZ.

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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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