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FDA 510(k)

ISOLATED EEG AMPLIFIER MODULE

K-Number: K770246 · 1977-02-14

ApplicantMennen Greatbatch Electonics
Decision Date1977-02-14
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISOLATED EEG AMPLIFIER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Greatbatch Electonics. It received FDA 510(k) clearance on 1977-02-14 under 510(k) number K770246. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLATED EEG AMPLIFIER MODULE?

ISOLATED EEG AMPLIFIER MODULE is a medical device that received FDA 510(k) clearance on 1977-02-14. The listed applicant is Mennen Greatbatch Electonics. The 510(k) number is K770246.

When did ISOLATED EEG AMPLIFIER MODULE receive FDA 510(k) clearance?

ISOLATED EEG AMPLIFIER MODULE received FDA 510(k) clearance on 1977-02-14, under 510(k) number K770246.

Who is the listed applicant for ISOLATED EEG AMPLIFIER MODULE?

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

What is the FDA product code for ISOLATED EEG AMPLIFIER MODULE?

The FDA product code for ISOLATED EEG AMPLIFIER MODULE is GWQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mennen Greatbatch Electonics 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.

K772000ECG TELEMETRY SYSTEMK770832PORTASCOPE IIK770279MONITOR, PORTABLE, PART #431-010K770247D.C. AMPLIFIER MODULEK770245ABDOMINAL FETAL ECG MODULE

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, 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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