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FDA 510(k)

MODEL WHO1 HEARING AID

K-Number: K823285 · 1982-11-29

ApplicantPanasonic Co. Div. Matsu Elec. Corp. America
Decision Date1982-11-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL WHO1 HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Panasonic Co. Div. Matsu Elec. Corp. America. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823285. 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 MODEL WHO1 HEARING AID?

MODEL WHO1 HEARING AID is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Panasonic Co. Div. Matsu Elec. Corp. America. The 510(k) number is K823285.

When did MODEL WHO1 HEARING AID receive FDA 510(k) clearance?

MODEL WHO1 HEARING AID received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823285.

Who is the listed applicant for MODEL WHO1 HEARING AID?

The FDA 510(k) record lists Panasonic Co. Div. Matsu Elec. Corp. America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL WHO1 HEARING AID?

The FDA product code for MODEL WHO1 HEARING AID is ESD.

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Other records listing Panasonic Co. Div. Matsu Elec. Corp. America 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.

K860634PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PPK841103NONINVASIVE BLOOD PRESSURE MEASURE SYSK832076ELECTRONIC BLOOD PRESS. METER EN-212K833510PANASONIC WH-50 HEARING AIDK832075ELECTRONIC BLOOD PRESS. METER-ZH-820PK831151PANASONIC MODEL EW-213

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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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