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FDA 510(k)

AD-TECH'S FORAMEN OVALE ELECTRODE

K-Number: K990788 · 1999-11-02

ApplicantAd-Tech Medical Instrument Corp
Decision Date1999-11-02
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AD-TECH'S FORAMEN OVALE 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 1999-11-02 under 510(k) number K990788. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AD-TECH'S FORAMEN OVALE ELECTRODE?

AD-TECH'S FORAMEN OVALE ELECTRODE is a medical device that received FDA 510(k) clearance on 1999-11-02. The listed applicant is Ad-Tech Medical Instrument Corp. The 510(k) number is K990788.

When did AD-TECH'S FORAMEN OVALE ELECTRODE receive FDA 510(k) clearance?

AD-TECH'S FORAMEN OVALE ELECTRODE received FDA 510(k) clearance on 1999-11-02, under 510(k) number K990788.

Who is the listed applicant for AD-TECH'S FORAMEN OVALE 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'S FORAMEN OVALE ELECTRODE?

The FDA product code for AD-TECH'S FORAMEN OVALE ELECTRODE is GZL.

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Other records listing Ad-Tech Medical Instrument Corp as applicant

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K112094BRAIN BIOPSY NEEDLEK053363DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODESK053358DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODESK041604MACRO-MICRO DEPTH ELECTRODEK992194CORTICAL MAPPING UNIT, MODEL CMUK973454AD-TECH'S SPINAL ELECTRODE

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Related Devices (Code: GZL)

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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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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