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FDA 510(k)

MACTRODE-II

K-Number: K872784 · 1987-10-09

ApplicantMarquette Electronics, Inc.
Decision Date1987-10-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MACTRODE-II is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1987-10-09 under 510(k) number K872784. 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 MACTRODE-II?

MACTRODE-II is a medical device that received FDA 510(k) clearance on 1987-10-09. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K872784.

When did MACTRODE-II receive FDA 510(k) clearance?

MACTRODE-II received FDA 510(k) clearance on 1987-10-09, under 510(k) number K872784.

Who is the listed applicant for MACTRODE-II?

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

What is the FDA product code for MACTRODE-II?

The FDA product code for MACTRODE-II is 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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