NEONATAL ECG ELECTRODE, M203KEN— 510(k) K092744

Substantially Equivalent

R & D Medical Products, Inc.

FDA 510(k) clearance K092744 for NEONATAL ECG ELECTRODE, M203KEN, Substantially Equivalent on 2009-12-10. Applicant: R & D Medical Products, Inc..

Clearance details

Applicant: R & D Medical Products, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2009-09-08
Decision date: 2009-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.