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FDA 510(k)

RE-HP SERIES HEARING AIDS

K-Number: K811522 · 1981-06-26

ApplicantRadioear Corp.
Decision Date1981-06-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RE-HP SERIES HEARING AIDS is the device name listed in this FDA 510(k) record. The listed applicant is Radioear Corp.. It received FDA 510(k) clearance on 1981-06-26 under 510(k) number K811522. 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 RE-HP SERIES HEARING AIDS?

RE-HP SERIES HEARING AIDS is a medical device that received FDA 510(k) clearance on 1981-06-26. The listed applicant is Radioear Corp.. The 510(k) number is K811522.

When did RE-HP SERIES HEARING AIDS receive FDA 510(k) clearance?

RE-HP SERIES HEARING AIDS received FDA 510(k) clearance on 1981-06-26, under 510(k) number K811522.

Who is the listed applicant for RE-HP SERIES HEARING AIDS?

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

What is the FDA product code for RE-HP SERIES HEARING AIDS?

The FDA product code for RE-HP SERIES HEARING AIDS is ESD.

Related Clinical Trials

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Other records listing Radioear Corp. 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.

K841934RADIOEAR M430 PPK841933RADIOEAR M420HK841474HEARING AID MODEL P500K841475HEARING AID MODEL M400K841473HEARING AID MODEL 440PPCK834523MODEL M410D HEARING AID

View all 14 devices →

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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