FDA 510(k)

SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES

K-Number: K895604 · 1989-10-13

ApplicantMedical Design & Manufacturing Corp.

Decision Date1989-10-13

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design & Manufacturing Corp.. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K895604. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES?

SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Medical Design & Manufacturing Corp.. The 510(k) number is K895604.

When did SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES receive FDA 510(k) clearance?

SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES received FDA 510(k) clearance on 1989-10-13, under 510(k) number K895604.

Who is the listed applicant for SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES?

The FDA 510(k) record lists Medical Design & Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES?

The FDA product code for SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES is GXY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.