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FDA 510(k)

OPTI-AMP DC-POWERED

K-Number: K052060 · 2005-08-31

ApplicantIntelligent Hearing Systems
Decision Date2005-08-31
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OPTI-AMP DC-POWERED 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 2005-08-31 under 510(k) number K052060. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI-AMP DC-POWERED?

OPTI-AMP DC-POWERED is a medical device that received FDA 510(k) clearance on 2005-08-31. The listed applicant is Intelligent Hearing Systems. The 510(k) number is K052060.

When did OPTI-AMP DC-POWERED receive FDA 510(k) clearance?

OPTI-AMP DC-POWERED received FDA 510(k) clearance on 2005-08-31, under 510(k) number K052060.

Who is the listed applicant for OPTI-AMP DC-POWERED?

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 OPTI-AMP DC-POWERED?

The FDA product code for OPTI-AMP DC-POWERED is GWL.

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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 M010000K063402WICK ELECTRODE, MODEL M019260K061443SMART USBLITE, MODEL M011120

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Related Devices (Code: GWL)

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.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

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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