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FDA 510(k)

EchoNavigator

K-Number: K200713 · 2020-04-09

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2020-04-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoNavigator is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K200713. 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?

EchoNavigator is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K200713.

When did EchoNavigator receive FDA 510(k) clearance?

EchoNavigator received FDA 510(k) clearance on 2020-04-09, under 510(k) number K200713.

Who is the listed applicant for EchoNavigator?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EchoNavigator?

The FDA product code for EchoNavigator is LLZ.

Other records listing Philips Medical Systems Nederland B.V. as applicant

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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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