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FDA 510(k)

543 SERIES BTE

K-Number: K905680 · 1991-03-08

ApplicantHearing Tech, Inc.
Decision Date1991-03-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

543 SERIES BTE is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Tech, Inc.. It received FDA 510(k) clearance on 1991-03-08 under 510(k) number K905680. 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 543 SERIES BTE?

543 SERIES BTE is a medical device that received FDA 510(k) clearance on 1991-03-08. The listed applicant is Hearing Tech, Inc.. The 510(k) number is K905680.

When did 543 SERIES BTE receive FDA 510(k) clearance?

543 SERIES BTE received FDA 510(k) clearance on 1991-03-08, under 510(k) number K905680.

Who is the listed applicant for 543 SERIES BTE?

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

What is the FDA product code for 543 SERIES BTE?

The FDA product code for 543 SERIES BTE is ESD.

Related Clinical Trials

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.

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Other records listing Hearing Tech, 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.

K941587HEARING TECHK924712ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEMK903295ESCORT ITCK903023HERITAGE III (HTC) ITC TYPE HEARING AIDK870723HEARTECH HFX, HEARING AIDK870350ESCORT EC CUSTOM IN-THE-EAR HEARING AID

View all 11 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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