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FDA 510(k)

AMX Navigate

K-Number: K210982 · 2021-04-28

ApplicantGe Medical Systems, LLC
Decision Date2021-04-28
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMX Navigate is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K210982. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMX Navigate?

AMX Navigate is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K210982.

When did AMX Navigate receive FDA 510(k) clearance?

AMX Navigate received FDA 510(k) clearance on 2021-04-28, under 510(k) number K210982.

Who is the listed applicant for AMX Navigate?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMX Navigate?

The FDA product code for AMX Navigate is IZL.

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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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