NR5000 E.C.G. AND PULSE OXIMETER MONITOR— 510(k) K894919

Name: FDA 510(k) clearance K894919
Creator: U.S. Food and Drug Administration
Published: 1989-09-18

Substantially Equivalent

Nirad , Ltd.

FDA 510(k) clearance K894919 for NR5000 E.C.G. AND PULSE OXIMETER MONITOR, Substantially Equivalent on 1989-09-18. Applicant: Nirad , Ltd.. Device class: 2.

Clearance details

Applicant: Nirad , Ltd.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1989-08-02
Decision date: 1989-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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K883903 — NR2000 CARDIAC MONITOR1989-03-09

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.