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FDA 510(k)

AMX-III

K-Number: K802047 · 1980-10-23

ApplicantGeneral Electric Co.
Decision Date1980-10-23
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMX-III is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802047. 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-III?

AMX-III is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is General Electric Co.. The 510(k) number is K802047.

When did AMX-III receive FDA 510(k) clearance?

AMX-III received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802047.

Who is the listed applicant for AMX-III?

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

What is the FDA product code for AMX-III?

The FDA product code for AMX-III 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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