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FDA 510(k)

MEDI-DX 7000 CPT WITH AMREX ELECTRODES

K-Number: K980866 · 1998-05-20

ApplicantNeuro-Diagnostic Assoc.
Decision Date1998-05-20
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDI-DX 7000 CPT WITH AMREX ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Neuro-Diagnostic Assoc.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K980866. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-DX 7000 CPT WITH AMREX ELECTRODES?

MEDI-DX 7000 CPT WITH AMREX ELECTRODES is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Neuro-Diagnostic Assoc.. The 510(k) number is K980866.

When did MEDI-DX 7000 CPT WITH AMREX ELECTRODES receive FDA 510(k) clearance?

MEDI-DX 7000 CPT WITH AMREX ELECTRODES received FDA 510(k) clearance on 1998-05-20, under 510(k) number K980866.

Who is the listed applicant for MEDI-DX 7000 CPT WITH AMREX ELECTRODES?

The FDA 510(k) record lists Neuro-Diagnostic Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-DX 7000 CPT WITH AMREX ELECTRODES?

The FDA product code for MEDI-DX 7000 CPT WITH AMREX ELECTRODES is GWF.

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.

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Other records listing Neuro-Diagnostic Assoc. 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.

K964622MEDI-DX 7000

Related Devices (Code: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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