Nihon Kohden NKV-330 Ventilator System— 510(k) K213521

Substantially Equivalent

Nihon Kohden Orangemed, Inc.

FDA 510(k) clearance K213521 for Nihon Kohden NKV-330 Ventilator System, Substantially Equivalent on 2022-07-01. Applicant: Nihon Kohden Orangemed, Inc..

Clearance details

Applicant: Nihon Kohden Orangemed, Inc.
Product code: Code MNT
Advisory panel: Anesthesiology
Date received: 2021-11-03
Decision date: 2022-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNT

product code MNT

Death: 118
Injury: 324
Malfunction: 25,451
Other: 2
Total: 25,895

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.