NR2000 CARDIAC MONITOR— 510(k) K883903

Substantially Equivalent

Nirad , Ltd.

FDA 510(k) clearance K883903 for NR2000 CARDIAC MONITOR, Substantially Equivalent on 1989-03-09. Applicant: Nirad , Ltd..

Clearance details

Applicant: Nirad , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1988-09-15
Decision date: 1989-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.