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FDA 510(k)

ELECTONE ITE MODEL PREMIER

K-Number: K910097 · 1991-04-03

ApplicantElectone, Inc.
Decision Date1991-04-03
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ELECTONE ITE MODEL PREMIER is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1991-04-03 under 510(k) number K910097. 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 ELECTONE ITE MODEL PREMIER?

ELECTONE ITE MODEL PREMIER is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Electone, Inc.. The 510(k) number is K910097.

When did ELECTONE ITE MODEL PREMIER receive FDA 510(k) clearance?

ELECTONE ITE MODEL PREMIER received FDA 510(k) clearance on 1991-04-03, under 510(k) number K910097.

Who is the listed applicant for ELECTONE ITE MODEL PREMIER?

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 ELECTONE ITE MODEL PREMIER?

The FDA product code for ELECTONE ITE MODEL PREMIER is ESD.

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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-IIK961084AM 400K955702SONATA U-01K953050Z33K953047Z20K953051Z35

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Related Devices (Code: ESD)

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.

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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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