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FDA 510(k)

CADWELL FREEDOM EEG DEVICE

K-Number: K894276 · 1989-09-29

ApplicantCadwell Laboratories, Inc.
Decision Date1989-09-29
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CADWELL FREEDOM EEG DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-29 under 510(k) number K894276. 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 CADWELL FREEDOM EEG DEVICE?

CADWELL FREEDOM EEG DEVICE is a medical device that received FDA 510(k) clearance on 1989-09-29. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K894276.

When did CADWELL FREEDOM EEG DEVICE receive FDA 510(k) clearance?

CADWELL FREEDOM EEG DEVICE received FDA 510(k) clearance on 1989-09-29, under 510(k) number K894276.

Who is the listed applicant for CADWELL FREEDOM EEG DEVICE?

The FDA 510(k) record lists Cadwell Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CADWELL FREEDOM EEG DEVICE?

The FDA product code for CADWELL FREEDOM EEG DEVICE is GWQ.

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Other records listing Cadwell Laboratories, Inc. 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.

K061706CADWELL EASYNET OXIMETER MODULEK061705CADWELL EASYNET NASAL PRESSURE MODULEK042350TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATORK040986CADWELL LIMB MOVEMENT MODULEK040932EASYNET BODY POSITION MODULEK971214KILOWIN

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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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