FDA 510(k)

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570

K-Number: K990111 · 1999-12-06

Decision Date1999-12-06

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 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 K990111. 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 4520, 4535, 4570?

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 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 K990111.

When did DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 receive FDA 510(k) clearance?

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 received FDA 510(k) clearance on 1999-12-06, under 510(k) number K990111.

Who is the listed applicant for DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570?

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 4520, 4535, 4570?

The FDA product code for DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 is DRX.

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Other records listing Maersk Medical A/S as applicant

K011071PARADIGM QUICK-SET INFUSION SET K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 K990110DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 K990113DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 K990112DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 K990115DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440

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Related Devices (Code: DRX)

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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.