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FDA 510(k)

FlightPlan for Liver

K-Number: K210807 · 2021-10-22

ApplicantGE Medical Systems SCS
Decision Date2021-10-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FlightPlan for Liver is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K210807. 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 FlightPlan for Liver?

FlightPlan for Liver is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is GE Medical Systems SCS. The 510(k) number is K210807.

When did FlightPlan for Liver receive FDA 510(k) clearance?

FlightPlan for Liver received FDA 510(k) clearance on 2021-10-22, under 510(k) number K210807.

Who is the listed applicant for FlightPlan for Liver?

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

What is the FDA product code for FlightPlan for Liver?

The FDA product code for FlightPlan for Liver 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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