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FDA 510(k)

RIONET &/OR RION HEARING AID MOD. HB-67S

K-Number: K800738 · 1980-04-24

ApplicantRion Acoustic Instruments, Inc.
Decision Date1980-04-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RIONET &/OR RION HEARING AID MOD. HB-67S 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 1980-04-24 under 510(k) number K800738. 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 &/OR RION HEARING AID MOD. HB-67S?

RIONET &/OR RION HEARING AID MOD. HB-67S is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Rion Acoustic Instruments, Inc.. The 510(k) number is K800738.

When did RIONET &/OR RION HEARING AID MOD. HB-67S receive FDA 510(k) clearance?

RIONET &/OR RION HEARING AID MOD. HB-67S received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800738.

Who is the listed applicant for RIONET &/OR RION HEARING AID MOD. HB-67S?

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 &/OR RION HEARING AID MOD. HB-67S?

The FDA product code for RIONET &/OR RION HEARING AID MOD. HB-67S 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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