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FDA 510(k)

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)

K-Number: K011364 · 2001-06-07

ApplicantSiemens Hearing Instruments, Inc.
Decision Date2001-06-07
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) 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 2001-06-07 under 510(k) number K011364. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)?

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) is a medical device that received FDA 510(k) clearance on 2001-06-07. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K011364.

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

CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) received FDA 510(k) clearance on 2001-06-07, under 510(k) number K011364.

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

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 CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)?

The FDA product code for CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) is KLW.

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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)K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K003559TCI (TINNITUS CONTROL INSTRUMENT)K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K972998PRISMAK962170SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP

View all 42 devices →

Related Devices (Code: KLW)

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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

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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