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FDA 510(k)

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

K-Number: K003804 · 2001-08-30

ApplicantNiko Medical Products
Decision Date2001-08-30
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 is the device name listed in this FDA 510(k) record. The listed applicant is Niko Medical Products. It received FDA 510(k) clearance on 2001-08-30 under 510(k) number K003804. 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 SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801?

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 is a medical device that received FDA 510(k) clearance on 2001-08-30. The listed applicant is Niko Medical Products. The 510(k) number is K003804.

When did SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 receive FDA 510(k) clearance?

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 received FDA 510(k) clearance on 2001-08-30, under 510(k) number K003804.

Who is the listed applicant for SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801?

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

What is the FDA product code for SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801?

The FDA product code for SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 is DRX.

Related Clinical Trials

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.

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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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