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FDA 510(k)

PERSONAL AMPLIFIER COMMUNICATOR PREMIUM

K-Number: K853606 · 1985-09-23

ApplicantElectone, Inc.
Decision Date1985-09-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PERSONAL AMPLIFIER COMMUNICATOR PREMIUM is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1985-09-23 under 510(k) number K853606. 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 COMMUNICATOR PREMIUM?

PERSONAL AMPLIFIER COMMUNICATOR PREMIUM is a medical device that received FDA 510(k) clearance on 1985-09-23. The listed applicant is Electone, Inc.. The 510(k) number is K853606.

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

PERSONAL AMPLIFIER COMMUNICATOR PREMIUM received FDA 510(k) clearance on 1985-09-23, under 510(k) number K853606.

Who is the listed applicant for PERSONAL AMPLIFIER COMMUNICATOR PREMIUM?

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 COMMUNICATOR PREMIUM?

The FDA product code for PERSONAL AMPLIFIER COMMUNICATOR PREMIUM 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-01K953047Z20K953050Z33K953053AM 260 PP

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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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.

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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