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FDA 510(k)

HORMANN HEARING INSTRUMENTS

K-Number: K945219 · 1995-01-20

ApplicantHormann, Inc.
Decision Date1995-01-20
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HORMANN HEARING INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Hormann, Inc.. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K945219. 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 HORMANN HEARING INSTRUMENTS?

HORMANN HEARING INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Hormann, Inc.. The 510(k) number is K945219.

When did HORMANN HEARING INSTRUMENTS receive FDA 510(k) clearance?

HORMANN HEARING INSTRUMENTS received FDA 510(k) clearance on 1995-01-20, under 510(k) number K945219.

Who is the listed applicant for HORMANN HEARING INSTRUMENTS?

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

What is the FDA product code for HORMANN HEARING INSTRUMENTS?

The FDA product code for HORMANN HEARING INSTRUMENTS is ESD.

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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

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

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