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FDA 510(k)

CORONET 100

K-Number: K913785 · 1991-12-31

ApplicantMicro-Shev , Ltd.
Decision Date1991-12-31
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CORONET 100 is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Shev , Ltd.. It received FDA 510(k) clearance on 1991-12-31 under 510(k) number K913785. 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 CORONET 100?

CORONET 100 is a medical device that received FDA 510(k) clearance on 1991-12-31. The listed applicant is Micro-Shev , Ltd.. The 510(k) number is K913785.

When did CORONET 100 receive FDA 510(k) clearance?

CORONET 100 received FDA 510(k) clearance on 1991-12-31, under 510(k) number K913785.

Who is the listed applicant for CORONET 100?

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

What is the FDA product code for CORONET 100?

The FDA product code for CORONET 100 is GWJ.

Related Clinical Trials

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Other records listing Micro-Shev , Ltd. 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.

K900378EMG OPTION FOR MICROSHEV 4000K894608MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEMK874193MICROSHEV MODEL 2000K792085C-ERA-100 COMPUTERIZED ELECTRIC RESPON

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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