FDA 510(k)

NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,

K-Number: K851305 · 1985-09-06

Decision Date1985-09-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1985-09-06 under 510(k) number K851305. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,?

NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, is a medical device that received FDA 510(k) clearance on 1985-09-06. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K851305.

When did NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, receive FDA 510(k) clearance?

NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, received FDA 510(k) clearance on 1985-09-06, under 510(k) number K851305.

Who is the listed applicant for NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,?

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

What is the FDA product code for NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,?

The FDA product code for NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, is GEI.

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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.