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FDA 510(k)

TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

K-Number: K003558 · 2001-04-24

ApplicantSiemens Hearing Instruments, Inc.
Decision Date2001-04-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Hearing Instruments, Inc.. It received FDA 510(k) clearance on 2001-04-24 under 510(k) number K003558. 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 TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)?

TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) is a medical device that received FDA 510(k) clearance on 2001-04-24. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K003558.

When did TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) receive FDA 510(k) clearance?

TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) received FDA 510(k) clearance on 2001-04-24, under 510(k) number K003558.

Who is the listed applicant for TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)?

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

What is the FDA product code for TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)?

The FDA product code for TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) is ESD.

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Other records listing Siemens Hearing Instruments, 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.

K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)K011364CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K003559TCI (TINNITUS CONTROL INSTRUMENT)K972998PRISMAK962170SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP

View all 42 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.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICGeneral Hearing Instruments, 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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