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FDA 510(k)

C-ERA-100 COMPUTERIZED ELECTRIC RESPON

K-Number: K792085 · 1979-10-30

ApplicantMicro-Shev , Ltd.
Decision Date1979-10-30
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

C-ERA-100 COMPUTERIZED ELECTRIC RESPON 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 1979-10-30 under 510(k) number K792085. 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 C-ERA-100 COMPUTERIZED ELECTRIC RESPON?

C-ERA-100 COMPUTERIZED ELECTRIC RESPON is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Micro-Shev , Ltd.. The 510(k) number is K792085.

When did C-ERA-100 COMPUTERIZED ELECTRIC RESPON receive FDA 510(k) clearance?

C-ERA-100 COMPUTERIZED ELECTRIC RESPON received FDA 510(k) clearance on 1979-10-30, under 510(k) number K792085.

Who is the listed applicant for C-ERA-100 COMPUTERIZED ELECTRIC RESPON?

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 C-ERA-100 COMPUTERIZED ELECTRIC RESPON?

The FDA product code for C-ERA-100 COMPUTERIZED ELECTRIC RESPON 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.

K913785CORONET 100K900378EMG OPTION FOR MICROSHEV 4000K894608MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEMK874193MICROSHEV MODEL 2000

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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