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FDA 510(k)

THE NEW 1600 ELECTRODE

K-Number: K812878 · 1981-11-02

ApplicantAndover Medical, Inc.
Decision Date1981-11-02
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE NEW 1600 ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812878. 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 THE NEW 1600 ELECTRODE?

THE NEW 1600 ELECTRODE is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Andover Medical, Inc.. The 510(k) number is K812878.

When did THE NEW 1600 ELECTRODE receive FDA 510(k) clearance?

THE NEW 1600 ELECTRODE received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812878.

Who is the listed applicant for THE NEW 1600 ELECTRODE?

The FDA 510(k) record lists Andover Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE NEW 1600 ELECTRODE?

The FDA product code for THE NEW 1600 ELECTRODE is DRX.

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Other records listing Andover Medical, Inc. 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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