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FDA 510(k)

SIEMENS MODEL INFINITI 1001 B

K-Number: K923379 · 1992-08-18

ApplicantSiemens Hearing Instruments, Inc.
Decision Date1992-08-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SIEMENS MODEL INFINITI 1001 B 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 1992-08-18 under 510(k) number K923379. 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 SIEMENS MODEL INFINITI 1001 B?

SIEMENS MODEL INFINITI 1001 B is a medical device that received FDA 510(k) clearance on 1992-08-18. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K923379.

When did SIEMENS MODEL INFINITI 1001 B receive FDA 510(k) clearance?

SIEMENS MODEL INFINITI 1001 B received FDA 510(k) clearance on 1992-08-18, under 510(k) number K923379.

Who is the listed applicant for SIEMENS MODEL INFINITI 1001 B?

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 SIEMENS MODEL INFINITI 1001 B?

The FDA product code for SIEMENS MODEL INFINITI 1001 B 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)K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K972998PRISMA

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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

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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