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FDA 510(k)

AUDIOSCAN VERIFIT, MODEL VF-1

K-Number: K012306 · 2001-09-21

ApplicantEtymonic Design, Inc.
Decision Date2001-09-21
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOSCAN VERIFIT, MODEL VF-1 is the device name listed in this FDA 510(k) record. The listed applicant is Etymonic Design, Inc.. It received FDA 510(k) clearance on 2001-09-21 under 510(k) number K012306. 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 AUDIOSCAN VERIFIT, MODEL VF-1?

AUDIOSCAN VERIFIT, MODEL VF-1 is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is Etymonic Design, Inc.. The 510(k) number is K012306.

When did AUDIOSCAN VERIFIT, MODEL VF-1 receive FDA 510(k) clearance?

AUDIOSCAN VERIFIT, MODEL VF-1 received FDA 510(k) clearance on 2001-09-21, under 510(k) number K012306.

Who is the listed applicant for AUDIOSCAN VERIFIT, MODEL VF-1?

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

What is the FDA product code for AUDIOSCAN VERIFIT, MODEL VF-1?

The FDA product code for AUDIOSCAN VERIFIT, MODEL VF-1 is ETW.

Related Clinical Trials

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Other records listing Etymonic Design, 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.

K884046AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500

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

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