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FDA 510(k)

WICK ELECTRODE, MODEL M019260

K-Number: K063402 · 2006-12-11

ApplicantIntelligent Hearing Systems
Decision Date2006-12-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WICK ELECTRODE, MODEL M019260 is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Hearing Systems. It received FDA 510(k) clearance on 2006-12-11 under 510(k) number K063402. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WICK ELECTRODE, MODEL M019260?

WICK ELECTRODE, MODEL M019260 is a medical device that received FDA 510(k) clearance on 2006-12-11. The listed applicant is Intelligent Hearing Systems. The 510(k) number is K063402.

When did WICK ELECTRODE, MODEL M019260 receive FDA 510(k) clearance?

WICK ELECTRODE, MODEL M019260 received FDA 510(k) clearance on 2006-12-11, under 510(k) number K063402.

Who is the listed applicant for WICK ELECTRODE, MODEL M019260?

The FDA 510(k) record lists Intelligent Hearing Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WICK ELECTRODE, MODEL M019260?

The FDA product code for WICK ELECTRODE, MODEL M019260 is GXY.

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 Intelligent Hearing Systems 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.

K163326SmartEPK090579SMARTSCREENER-PLUS2K073384SMART COUPLER, MODEL M015401K070608SMARTEP, MODEL M010000K061443SMART USBLITE, MODEL M011120K052060OPTI-AMP DC-POWERED

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Related Devices (Code: GXY)

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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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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