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FDA 510(k)

RIONET HEARING AID HI-03

K-Number: K841935 · 1984-08-14

ApplicantRion Acoustic Instruments, Inc.
Decision Date1984-08-14
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RIONET HEARING AID HI-03 is the device name listed in this FDA 510(k) record. The listed applicant is Rion Acoustic Instruments, Inc.. It received FDA 510(k) clearance on 1984-08-14 under 510(k) number K841935. 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 RIONET HEARING AID HI-03?

RIONET HEARING AID HI-03 is a medical device that received FDA 510(k) clearance on 1984-08-14. The listed applicant is Rion Acoustic Instruments, Inc.. The 510(k) number is K841935.

When did RIONET HEARING AID HI-03 receive FDA 510(k) clearance?

RIONET HEARING AID HI-03 received FDA 510(k) clearance on 1984-08-14, under 510(k) number K841935.

Who is the listed applicant for RIONET HEARING AID HI-03?

The FDA 510(k) record lists Rion Acoustic Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIONET HEARING AID HI-03?

The FDA product code for RIONET HEARING AID HI-03 is ESD.

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Other records listing Rion Acoustic Instruments, 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.

K874510RIONET HEARING AID HB-75K862670RIONET HEARING AID HB-35PTK861728RIONET HEARING AIDK853637RIONET HEARING AID HI-07K853636RIONET HEARING AID HI-06K853638RIONET HEARING AID

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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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