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FDA 510(k)

NEUROWAVE SYSTEM 2

K-Number: K883557 · 1988-12-16

ApplicantDurden Enterprises, Inc.
Decision Date1988-12-16
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROWAVE SYSTEM 2 is the device name listed in this FDA 510(k) record. The listed applicant is Durden Enterprises, Inc.. It received FDA 510(k) clearance on 1988-12-16 under 510(k) number K883557. 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 NEUROWAVE SYSTEM 2?

NEUROWAVE SYSTEM 2 is a medical device that received FDA 510(k) clearance on 1988-12-16. The listed applicant is Durden Enterprises, Inc.. The 510(k) number is K883557.

When did NEUROWAVE SYSTEM 2 receive FDA 510(k) clearance?

NEUROWAVE SYSTEM 2 received FDA 510(k) clearance on 1988-12-16, under 510(k) number K883557.

Who is the listed applicant for NEUROWAVE SYSTEM 2?

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

What is the FDA product code for NEUROWAVE SYSTEM 2?

The FDA product code for NEUROWAVE SYSTEM 2 is GWQ.

Related Clinical Trials

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Other records listing Durden Enterprises, 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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