FDA 510(k)

EM III DISPOSABLE ELECTRODE

K-Number: K863845 · 1986-11-20

Decision Date1986-11-20

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EM III DISPOSABLE 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 1986-11-20 under 510(k) number K863845. 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 III DISPOSABLE ELECTRODE?

EM III DISPOSABLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-11-20. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K863845.

When did EM III DISPOSABLE ELECTRODE receive FDA 510(k) clearance?

EM III DISPOSABLE ELECTRODE received FDA 510(k) clearance on 1986-11-20, under 510(k) number K863845.

Who is the listed applicant for EM III DISPOSABLE 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 III DISPOSABLE ELECTRODE?

The FDA product code for EM III DISPOSABLE 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.