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FDA 510(k)

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

K-Number: K071462 · 2007-06-05

ApplicantSiemens Hearing Instruments, Inc.
Decision Date2007-06-05
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) 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 2007-06-05 under 510(k) number K071462. 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 UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)?

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) is a medical device that received FDA 510(k) clearance on 2007-06-05. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K071462.

When did UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) receive FDA 510(k) clearance?

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) received FDA 510(k) clearance on 2007-06-05, under 510(k) number K071462.

Who is the listed applicant for UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)?

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 UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)?

The FDA product code for UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) is ETW.

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Other records listing Siemens Hearing Instruments, Inc. as applicant

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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.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/SK050496REM440Interacoustics A/S, Assens

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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