K093308

Substantially Equivalent

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

Applicant: Nidek Medical Products, Inc.
Product code: CAW
Advisory panel: Anesthesiology
Date received: 2009-10-22
Decision date: 2010-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Birmingham, AL, US

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.