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FDA 510(k)

SELF-RETAINING ELECTRODE SER. #4000-100

K-Number: K780908 · 1978-06-19

ApplicantAndover Medical, Inc.
Decision Date1978-06-19
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SELF-RETAINING ELECTRODE SER. #4000-100 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 1978-06-19 under 510(k) number K780908. 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 SELF-RETAINING ELECTRODE SER. #4000-100?

SELF-RETAINING ELECTRODE SER. #4000-100 is a medical device that received FDA 510(k) clearance on 1978-06-19. The listed applicant is Andover Medical, Inc.. The 510(k) number is K780908.

When did SELF-RETAINING ELECTRODE SER. #4000-100 receive FDA 510(k) clearance?

SELF-RETAINING ELECTRODE SER. #4000-100 received FDA 510(k) clearance on 1978-06-19, under 510(k) number K780908.

Who is the listed applicant for SELF-RETAINING ELECTRODE SER. #4000-100?

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 SELF-RETAINING ELECTRODE SER. #4000-100?

The FDA product code for SELF-RETAINING ELECTRODE SER. #4000-100 is DRX.

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Related Devices (Code: DRX)

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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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