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FDA 510(k)

DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER

K-Number: K854268 · 1986-03-27

ApplicantDel Mar Avionics
Decision Date1986-03-27
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1986-03-27 under 510(k) number K854268. 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 DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER?

DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER is a medical device that received FDA 510(k) clearance on 1986-03-27. The listed applicant is Del Mar Avionics. The 510(k) number is K854268.

When did DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER receive FDA 510(k) clearance?

DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER received FDA 510(k) clearance on 1986-03-27, under 510(k) number K854268.

Who is the listed applicant for DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER?

The FDA 510(k) record lists Del Mar Avionics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER?

The FDA product code for DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER is GWQ.

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Other records listing Del Mar Avionics as applicant

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K990027OMNICORDER, MODEL 464K971696SENTINEL RECORDER, MODELS 471/472K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)K950020HOLTER PACERCORDER(R)K942653HOLTER SSR DIGICORDER(TM)K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

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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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