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FDA 510(k)

Q-MED ELECTRODE

K-Number: K840465 · 1984-06-19

ApplicantQmed, Inc.
Decision Date1984-06-19
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Q-MED 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 1984-06-19 under 510(k) number K840465. 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 Q-MED ELECTRODE?

Q-MED ELECTRODE is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is Qmed, Inc.. The 510(k) number is K840465.

When did Q-MED ELECTRODE receive FDA 510(k) clearance?

Q-MED ELECTRODE received FDA 510(k) clearance on 1984-06-19, under 510(k) number K840465.

Who is the listed applicant for Q-MED 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 Q-MED ELECTRODE?

The FDA product code for Q-MED ELECTRODE is DRX.

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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)K862377QMED SELF ADHERING ELECTRODE

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Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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