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FDA 510(k)

EM II DISPOSABLE ELECTRODE

K-Number: K863540 · 1986-12-08

ApplicantElectromed Intl., Ltd.
Decision Date1986-12-08
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EM II 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 1986-12-08 under 510(k) number K863540. 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 II DISPOSABLE ELECTRODE?

EM II DISPOSABLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-12-08. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K863540.

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

EM II DISPOSABLE ELECTRODE received FDA 510(k) clearance on 1986-12-08, under 510(k) number K863540.

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

The FDA product code for EM II DISPOSABLE ELECTRODE is DRX.

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Other records listing Electromed Intl., Ltd. 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.

K003688VIEW READING STATIONK000474VIEW NTK990759VIEW COMK974255CD-R STATION AND VRS-2000K971176VIEW ARCHIVING STATIONK950694COMPACT-X

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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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