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FDA 510(k)

EVOKED RESPONSE SYS., MODEL 10

K-Number: K771742 · 1977-11-22

ApplicantGrass Instrument Co.
Decision Date1977-11-22
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EVOKED RESPONSE SYS., MODEL 10 is the device name listed in this FDA 510(k) record. The listed applicant is Grass Instrument Co.. It received FDA 510(k) clearance on 1977-11-22 under 510(k) number K771742. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOKED RESPONSE SYS., MODEL 10?

EVOKED RESPONSE SYS., MODEL 10 is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Grass Instrument Co.. The 510(k) number is K771742.

When did EVOKED RESPONSE SYS., MODEL 10 receive FDA 510(k) clearance?

EVOKED RESPONSE SYS., MODEL 10 received FDA 510(k) clearance on 1977-11-22, under 510(k) number K771742.

Who is the listed applicant for EVOKED RESPONSE SYS., MODEL 10?

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

What is the FDA product code for EVOKED RESPONSE SYS., MODEL 10?

The FDA product code for EVOKED RESPONSE SYS., MODEL 10 is GWK.

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Other records listing Grass Instrument Co. 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.

K021807GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEMK994142GRASS TS3201/6401 EEG AMPLIFIER SYSTEMK844216GRASS MODEL NL FACIAL NERVE LOCATOR & MONITORK812061MODEL S10VS VISUAL STIMULATORK810539MODEL S10CTCM AUDITORY STIMULATOR

Related Devices (Code: GWK)

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.

K060919ACTICALRespironics, Inc.K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K991045MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.

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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