Neonatal ECG Electrode, M203KEN

FDA 510(k) K092744 · R & D Medical Products, Inc.

Substantially Equivalent

510(k) numberK092744

Submission

Device name
Neonatal ECG Electrode, M203KEN
Applicant
R & D Medical Products, Inc.
Lake Forest, CA, US
Received
September 8, 2009
Decision date
December 10, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRX – Electrode, Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2360
Specialty
Cardiovascular

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Questions and answers

When was Neonatal ECG Electrode, M203KEN cleared by the FDA?

Neonatal ECG Electrode, M203KEN (K092744) received a 510(k) decision of Substantially Equivalent on December 10, 2009, 93 days after the submission was received.

What is the product code of K092744?

The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.