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FDA 510(k)

MEDITRACE PELLET ELECTRODE

K-Number: K821137 · 1982-05-18

ApplicantGraphic Controls Corp.
Decision Date1982-05-18
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDITRACE PELLET ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K821137. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDITRACE PELLET ELECTRODE?

MEDITRACE PELLET ELECTRODE is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Graphic Controls Corp.. The 510(k) number is K821137.

When did MEDITRACE PELLET ELECTRODE receive FDA 510(k) clearance?

MEDITRACE PELLET ELECTRODE received FDA 510(k) clearance on 1982-05-18, under 510(k) number K821137.

Who is the listed applicant for MEDITRACE PELLET ELECTRODE?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDITRACE PELLET ELECTRODE?

The FDA product code for MEDITRACE PELLET ELECTRODE is DRX.

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Other records listing Graphic Controls Corp. as applicant

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Related Devices (Code: DRX)

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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