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FDA 510(k)

ECHO-SCREEN T, TA, TD, TDA, TC

K-Number: K013977 · 2002-06-14

ApplicantFischer-Zoth Audiologic Systems, Inc.
Decision Date2002-06-14
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECHO-SCREEN T, TA, TD, TDA, TC is the device name listed in this FDA 510(k) record. The listed applicant is Fischer-Zoth Audiologic Systems, Inc.. It received FDA 510(k) clearance on 2002-06-14 under 510(k) number K013977. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO-SCREEN T, TA, TD, TDA, TC?

ECHO-SCREEN T, TA, TD, TDA, TC is a medical device that received FDA 510(k) clearance on 2002-06-14. The listed applicant is Fischer-Zoth Audiologic Systems, Inc.. The 510(k) number is K013977.

When did ECHO-SCREEN T, TA, TD, TDA, TC receive FDA 510(k) clearance?

ECHO-SCREEN T, TA, TD, TDA, TC received FDA 510(k) clearance on 2002-06-14, under 510(k) number K013977.

Who is the listed applicant for ECHO-SCREEN T, TA, TD, TDA, TC?

The FDA 510(k) record lists Fischer-Zoth Audiologic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHO-SCREEN T, TA, TD, TDA, TC?

The FDA product code for ECHO-SCREEN T, TA, TD, TDA, TC is GWJ.

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 Fischer-Zoth Audiologic Systems, 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.

K982642ECHO-SCREEN

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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