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FDA 510(k)

MONITRODE

K-Number: K903491 · 1990-12-17

ApplicantLleventon
Decision Date1990-12-17
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITRODE is the device name listed in this FDA 510(k) record. The listed applicant is Lleventon. It received FDA 510(k) clearance on 1990-12-17 under 510(k) number K903491. 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 MONITRODE?

MONITRODE is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is Lleventon. The 510(k) number is K903491.

When did MONITRODE receive FDA 510(k) clearance?

MONITRODE received FDA 510(k) clearance on 1990-12-17, under 510(k) number K903491.

Who is the listed applicant for MONITRODE?

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

What is the FDA product code for MONITRODE?

The FDA product code for MONITRODE is DRX.

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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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