MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD— 510(k) K093308

Substantially Equivalent

Nidek Medical Products, Inc.

FDA 510(k) clearance K093308 for MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD, Substantially Equivalent on 2010-01-14. Applicant: Nidek Medical Products, Inc..

Clearance details

Applicant: Nidek Medical Products, Inc.
Product code: 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

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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.