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FDA 510(k)

SIEGEN HEADPHONES

K-Number: K862430 · 1986-09-26

ApplicantSiegen Corp.
Decision Date1986-09-26
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SIEGEN HEADPHONES is the device name listed in this FDA 510(k) record. The listed applicant is Siegen Corp.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K862430. 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 SIEGEN HEADPHONES?

SIEGEN HEADPHONES is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Siegen Corp.. The 510(k) number is K862430.

When did SIEGEN HEADPHONES receive FDA 510(k) clearance?

SIEGEN HEADPHONES received FDA 510(k) clearance on 1986-09-26, under 510(k) number K862430.

Who is the listed applicant for SIEGEN HEADPHONES?

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

What is the FDA product code for SIEGEN HEADPHONES?

The FDA product code for SIEGEN HEADPHONES is GWJ.

Related Clinical Trials

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Other records listing Siegen Corp. 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.

K871964SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.K861884NEUROSCOPE SEEGK844616SIEGEN VISUAL STIMULATORK844646SIEGEN SURFACE ELECTRODESK843464SIEGEN NEUROSCOPE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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