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FDA 510(k)

PERSONAL AMPLIFIER SILENCER

K-Number: K843980 · 1984-11-16

ApplicantElectone, Inc.
Decision Date1984-11-16
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PERSONAL AMPLIFIER SILENCER is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1984-11-16 under 510(k) number K843980. 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 PERSONAL AMPLIFIER SILENCER?

PERSONAL AMPLIFIER SILENCER is a medical device that received FDA 510(k) clearance on 1984-11-16. The listed applicant is Electone, Inc.. The 510(k) number is K843980.

When did PERSONAL AMPLIFIER SILENCER receive FDA 510(k) clearance?

PERSONAL AMPLIFIER SILENCER received FDA 510(k) clearance on 1984-11-16, under 510(k) number K843980.

Who is the listed applicant for PERSONAL AMPLIFIER SILENCER?

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 PERSONAL AMPLIFIER SILENCER?

The FDA product code for PERSONAL AMPLIFIER SILENCER 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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