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FDA 510(k)

EXCEL AV STIM 1000

K-Number: K972157 · 1998-01-30

ApplicantExcel Tech. , Ltd.
Decision Date1998-01-30
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXCEL AV STIM 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 1998-01-30 under 510(k) number K972157. 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 EXCEL AV STIM 1000?

EXCEL AV STIM 1000 is a medical device that received FDA 510(k) clearance on 1998-01-30. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K972157.

When did EXCEL AV STIM 1000 receive FDA 510(k) clearance?

EXCEL AV STIM 1000 received FDA 510(k) clearance on 1998-01-30, under 510(k) number K972157.

Who is the listed applicant for EXCEL AV STIM 1000?

The FDA 510(k) record lists Excel Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCEL AV STIM 1000?

The FDA product code for EXCEL AV STIM 1000 is GWJ.

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Other records listing Excel Tech. , Ltd. as applicant

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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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