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FDA 510(k)

ECG MONITORING/DEFIBRILLATION ELECTRODE

K-Number: K854433 · 1986-05-08

ApplicantAndover Medical, Inc.
Decision Date1986-05-08
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG MONITORING/DEFIBRILLATION ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1986-05-08 under 510(k) number K854433. 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 ECG MONITORING/DEFIBRILLATION ELECTRODE?

ECG MONITORING/DEFIBRILLATION ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-05-08. The listed applicant is Andover Medical, Inc.. The 510(k) number is K854433.

When did ECG MONITORING/DEFIBRILLATION ELECTRODE receive FDA 510(k) clearance?

ECG MONITORING/DEFIBRILLATION ELECTRODE received FDA 510(k) clearance on 1986-05-08, under 510(k) number K854433.

Who is the listed applicant for ECG MONITORING/DEFIBRILLATION ELECTRODE?

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

What is the FDA product code for ECG MONITORING/DEFIBRILLATION ELECTRODE?

The FDA product code for ECG MONITORING/DEFIBRILLATION ELECTRODE is DRX.

Related Clinical Trials

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Other records listing Andover Medical, 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.

K905729CANMED 451K903427NORTECH MODEL 86901000 ELECTRODEK885171MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLEK860636FASTRACE III, ECG ELECTRODEK860535UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)K860283AMI CARDIO-PAD

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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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