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FDA 510(k)

SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID

K-Number: K912665 · 1991-07-24

ApplicantResound Corp.
Decision Date1991-07-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Resound Corp.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K912665. 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 SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID?

SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Resound Corp.. The 510(k) number is K912665.

When did SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID receive FDA 510(k) clearance?

SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID received FDA 510(k) clearance on 1991-07-24, under 510(k) number K912665.

Who is the listed applicant for SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID?

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

What is the FDA product code for SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID?

The FDA product code for SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID is ESD.

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Other records listing Resound 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.

K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDSK974081RESOUND STEALTH CICK974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)K971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONK970215AUDALLION II HEARING SYSTEMK964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

View all 41 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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