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FDA 510(k)

NEONATAL ECG ELECTRODE, M203KEN

K-Number: K092744 · 2009-12-10

ApplicantR & D Medical Products, Inc.
Decision Date2009-12-10
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEONATAL ECG ELECTRODE, M203KEN is the device name listed in this FDA 510(k) record. The listed applicant is R & D Medical Products, Inc.. It received FDA 510(k) clearance on 2009-12-10 under 510(k) number K092744. 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 NEONATAL ECG ELECTRODE, M203KEN?

NEONATAL ECG ELECTRODE, M203KEN is a medical device that received FDA 510(k) clearance on 2009-12-10. The listed applicant is R & D Medical Products, Inc.. The 510(k) number is K092744.

When did NEONATAL ECG ELECTRODE, M203KEN receive FDA 510(k) clearance?

NEONATAL ECG ELECTRODE, M203KEN received FDA 510(k) clearance on 2009-12-10, under 510(k) number K092744.

Who is the listed applicant for NEONATAL ECG ELECTRODE, M203KEN?

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

What is the FDA product code for NEONATAL ECG ELECTRODE, M203KEN?

The FDA product code for NEONATAL ECG ELECTRODE, M203KEN is DRX.

Related Clinical Trials

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Other records listing R & D Medical Products, 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.

K111555CIRCUMAURAL ADHESIVE REPLACEMENTK001117COMFORT STIMK973183WOUND DRAINAGE HOLDER

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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