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FDA 510(k)

QMED SELF ADHERING ELECTRODE

K-Number: K862377 · 1986-09-26

ApplicantQmed, Inc.
Decision Date1986-09-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QMED SELF ADHERING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Qmed, Inc.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K862377. 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 QMED SELF ADHERING ELECTRODE?

QMED SELF ADHERING ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Qmed, Inc.. The 510(k) number is K862377.

When did QMED SELF ADHERING ELECTRODE receive FDA 510(k) clearance?

QMED SELF ADHERING ELECTRODE received FDA 510(k) clearance on 1986-09-26, under 510(k) number K862377.

Who is the listed applicant for QMED SELF ADHERING ELECTRODE?

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

What is the FDA product code for QMED SELF ADHERING ELECTRODE?

The FDA product code for QMED SELF ADHERING ELECTRODE is GXY.

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Other records listing Qmed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972991MONITOR ONE NDXK932109PROFILOMATK921476INTERP-1000K897121QEKG ELECTROCARDIOGRAPHK873591A.R.M. (ASPEN RETURN MONITOR)K863091BICORD BY QMED

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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