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FDA 510(k)

ELECTRODE SERIES 1600

K-Number: K760358 · 1976-08-23

ApplicantAndover Medical, Inc.
Decision Date1976-08-23
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRODE SERIES 1600 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 1976-08-23 under 510(k) number K760358. 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 ELECTRODE SERIES 1600?

ELECTRODE SERIES 1600 is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is Andover Medical, Inc.. The 510(k) number is K760358.

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

ELECTRODE SERIES 1600 received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760358.

Who is the listed applicant for ELECTRODE SERIES 1600?

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 ELECTRODE SERIES 1600?

The FDA product code for ELECTRODE SERIES 1600 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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