FDA 510(k)

AM 300 XP

K-Number: K914947 · 1992-02-18

Decision Date1992-02-18

Product CodeESD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

AM 300 XP is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K914947. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AM 300 XP?

AM 300 XP is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Electone, Inc.. The 510(k) number is K914947.

When did AM 300 XP receive FDA 510(k) clearance?

AM 300 XP received FDA 510(k) clearance on 1992-02-18, under 510(k) number K914947.

Who is the listed applicant for AM 300 XP?

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

What is the FDA product code for AM 300 XP?

The FDA product code for AM 300 XP is ESD.

Other records listing Electone, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973266Z DEQ-II K961084AM 400 K955702SONATA U-01 K953050Z33 K953047Z20 K953051Z35

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Related Devices (Code: ESD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.