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FDA 510(k)

EVOKED RESPONSE STIMULATORS

K-Number: K803226 · 1981-02-05

ApplicantBio-Logic Systems Corp.
Decision Date1981-02-05
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EVOKED RESPONSE STIMULATORS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Systems Corp.. It received FDA 510(k) clearance on 1981-02-05 under 510(k) number K803226. 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 STIMULATORS?

EVOKED RESPONSE STIMULATORS is a medical device that received FDA 510(k) clearance on 1981-02-05. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K803226.

When did EVOKED RESPONSE STIMULATORS receive FDA 510(k) clearance?

EVOKED RESPONSE STIMULATORS received FDA 510(k) clearance on 1981-02-05, under 510(k) number K803226.

Who is the listed applicant for EVOKED RESPONSE STIMULATORS?

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

What is the FDA product code for EVOKED RESPONSE STIMULATORS?

The FDA product code for EVOKED RESPONSE STIMULATORS is GWK.

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Other records listing Bio-Logic Systems 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.

K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMK061744COCHLEA-SCAN / COCHLEA-SCAN PLUSK052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELERK031352BIO-LOGIC INSERT EARPHONES

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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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