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FDA 510(k)

FXA (TM)

K-Number: K110765 · 2011-11-04

ApplicantAces GmbH
Decision Date2011-11-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FXA (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Aces GmbH. It received FDA 510(k) clearance on 2011-11-04 under 510(k) number K110765. 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 FXA (TM)?

FXA (TM) is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is Aces GmbH. The 510(k) number is K110765.

When did FXA (TM) receive FDA 510(k) clearance?

FXA (TM) received FDA 510(k) clearance on 2011-11-04, under 510(k) number K110765.

Who is the listed applicant for FXA (TM)?

The FDA 510(k) record lists Aces GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FXA (TM)?

The FDA product code for FXA (TM) 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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