K843531

Substantially Equivalent

ASN MONITOR SINGLE NEEDLE MONITOR

Applicant: Organon Teknika Corp.
Product code: KOC
Advisory panel: Gastroenterology, Urology
Date received: 1984-09-07
Decision date: 1984-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Adverse events under product code KOC

product code KOC

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.