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FDA 510(k)

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE

K-Number: K952098 · 1995-05-25

ApplicantSiemens Hearing Instruments, Inc.
Decision Date1995-05-25
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE 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 1995-05-25 under 510(k) number K952098. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE?

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K952098.

When did SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE receive FDA 510(k) clearance?

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE received FDA 510(k) clearance on 1995-05-25, under 510(k) number K952098.

Who is the listed applicant for SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE?

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 PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE?

The FDA product code for SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE is ETW.

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 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

View all 42 devices →

Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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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