FDA 510(k)

HAE 1

K-Number: K942829 · 1994-07-20

Decision Date1994-07-20

Product CodeESD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

HAE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Aid Express. It received FDA 510(k) clearance on 1994-07-20 under 510(k) number K942829. 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 HAE 1?

HAE 1 is a medical device that received FDA 510(k) clearance on 1994-07-20. The listed applicant is Hearing Aid Express. The 510(k) number is K942829.

When did HAE 1 receive FDA 510(k) clearance?

HAE 1 received FDA 510(k) clearance on 1994-07-20, under 510(k) number K942829.

Who is the listed applicant for HAE 1?

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

What is the FDA product code for HAE 1?

The FDA product code for HAE 1 is ESD.

Other records listing Hearing Aid Express 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.

K942831HAE 2 K942830HAE 3 K894428HEARING AID (IN-THE-EAR)K894414HEARING AID (IN-THE-CANAL)

Related Devices (Code: ESD)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.