FDA 510(k)

ALL-IN-THE-EAR

K-Number: K943318 · 1994-09-16

Decision Date1994-09-16

Product CodeESD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

ALL-IN-THE-EAR is the device name listed in this FDA 510(k) record. The listed applicant is Golden State Audiology Assoc.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K943318. 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 ALL-IN-THE-EAR?

ALL-IN-THE-EAR is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Golden State Audiology Assoc.. The 510(k) number is K943318.

When did ALL-IN-THE-EAR receive FDA 510(k) clearance?

ALL-IN-THE-EAR received FDA 510(k) clearance on 1994-09-16, under 510(k) number K943318.

Who is the listed applicant for ALL-IN-THE-EAR?

The FDA 510(k) record lists Golden State Audiology Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALL-IN-THE-EAR?

The FDA product code for ALL-IN-THE-EAR is ESD.

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 AG K130790LYRIC2Phonak, LLC K081136LYRIC 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.