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FDA 510(k)

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610

K-Number: K990112 · 1999-12-06

ApplicantMaersk Medical A/S
Decision Date1999-12-06
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 is the device name listed in this FDA 510(k) record. The listed applicant is Maersk Medical A/S. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K990112. 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 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610?

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Maersk Medical A/S. The 510(k) number is K990112.

When did DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 receive FDA 510(k) clearance?

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 received FDA 510(k) clearance on 1999-12-06, under 510(k) number K990112.

Who is the listed applicant for DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610?

The FDA 510(k) record lists Maersk Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610?

The FDA product code for DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 is DRX.

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Other records listing Maersk Medical A/S 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.

K011071PARADIGM QUICK-SET INFUSION SETK002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380K990111DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570K990110DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140K990113DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560K990115DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440

View all 9 devices →

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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