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FDA 510(k)

DISPOSABLE ELECTRODE #1900

K-Number: K822798 · 1982-10-15

ApplicantAndover Medical, Inc.
Decision Date1982-10-15
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ELECTRODE #1900 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 1982-10-15 under 510(k) number K822798. 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 DISPOSABLE ELECTRODE #1900?

DISPOSABLE ELECTRODE #1900 is a medical device that received FDA 510(k) clearance on 1982-10-15. The listed applicant is Andover Medical, Inc.. The 510(k) number is K822798.

When did DISPOSABLE ELECTRODE #1900 receive FDA 510(k) clearance?

DISPOSABLE ELECTRODE #1900 received FDA 510(k) clearance on 1982-10-15, under 510(k) number K822798.

Who is the listed applicant for DISPOSABLE ELECTRODE #1900?

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 DISPOSABLE ELECTRODE #1900?

The FDA product code for DISPOSABLE ELECTRODE #1900 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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