SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801— 510(k) K003804

Name: FDA 510(k) clearance K003804
Creator: U.S. Food and Drug Administration
Published: 2001-08-30

Substantially Equivalent

Niko Medical Products

FDA 510(k) clearance K003804 for SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801, Substantially Equivalent on 2001-08-30. Applicant: Niko Medical Products. Device class: 2.

Clearance details

Applicant: Niko Medical Products
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 2000-12-08
Decision date: 2001-08-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRX

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K171244 — Physiotrace2017-08-23
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K123658 — BIOMODULE 3-M12013-04-24
K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES2010-07-22
K101685 — IP-SET2010-07-01

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.