FDA 510(k)

AD-TECH SUBDURAL ELECTRODE

K-Number: K970587 · 1997-05-09

ApplicantAd-Tech Medical Instrument Corp

Decision Date1997-05-09

Product CodeGYC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AD-TECH SUBDURAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corp. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K970587. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AD-TECH SUBDURAL ELECTRODE?

AD-TECH SUBDURAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Ad-Tech Medical Instrument Corp. The 510(k) number is K970587.

When did AD-TECH SUBDURAL ELECTRODE receive FDA 510(k) clearance?

AD-TECH SUBDURAL ELECTRODE received FDA 510(k) clearance on 1997-05-09, under 510(k) number K970587.

Who is the listed applicant for AD-TECH SUBDURAL ELECTRODE?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AD-TECH SUBDURAL ELECTRODE?

The FDA product code for AD-TECH SUBDURAL ELECTRODE is GYC.

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Other records listing Ad-Tech Medical Instrument Corp as applicant

K112094BRAIN BIOPSY NEEDLE K053363DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES K053358DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES K041604MACRO-MICRO DEPTH ELECTRODE K990788AD-TECH'S FORAMEN OVALE ELECTRODE K992194CORTICAL MAPPING UNIT, MODEL CMU

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Related Devices (Code: GYC)

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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.