FDA 510(k)

EM II STRESS TEST ELECTRODE

K-Number: K863584 · 1986-12-08

Decision Date1986-12-08

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EM II STRESS TEST ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Electromed Intl., Ltd.. It received FDA 510(k) clearance on 1986-12-08 under 510(k) number K863584. 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 EM II STRESS TEST ELECTRODE?

EM II STRESS TEST ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-12-08. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K863584.

When did EM II STRESS TEST ELECTRODE receive FDA 510(k) clearance?

EM II STRESS TEST ELECTRODE received FDA 510(k) clearance on 1986-12-08, under 510(k) number K863584.

Who is the listed applicant for EM II STRESS TEST ELECTRODE?

The FDA 510(k) record lists Electromed Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EM II STRESS TEST ELECTRODE?

The FDA product code for EM II STRESS TEST ELECTRODE 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.