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FDA 510(k)

FONIX ,MODEL 8000

K-Number: K093006 · 2009-12-30

ApplicantFrye Electronics, Inc.
Decision Date2009-12-30
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FONIX ,MODEL 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Frye Electronics, Inc.. It received FDA 510(k) clearance on 2009-12-30 under 510(k) number K093006. 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 FONIX ,MODEL 8000?

FONIX ,MODEL 8000 is a medical device that received FDA 510(k) clearance on 2009-12-30. The listed applicant is Frye Electronics, Inc.. The 510(k) number is K093006.

When did FONIX ,MODEL 8000 receive FDA 510(k) clearance?

FONIX ,MODEL 8000 received FDA 510(k) clearance on 2009-12-30, under 510(k) number K093006.

Who is the listed applicant for FONIX ,MODEL 8000?

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

What is the FDA product code for FONIX ,MODEL 8000?

The FDA product code for FONIX ,MODEL 8000 is ETW.

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Other records listing Frye Electronics, 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.

K123701HEARLAB ACAK022510FONIX, MODEL 7000K980377FONIX FP35 HEARING AID ANALYZERK935400FONIX 3500 HEARING AID ANALYZERK913221TYPE FA10 AUDIOMETERK895383TYPE FP40 DIGITAL HEARING AID ANALYZER

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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/SK071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, 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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