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

Name: FDA 510(k) clearance K213521
Creator: U.S. Food and Drug Administration
Published: 2022-07-01

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.. Device class: 2.

Clearance details

Applicant: Nihon Kohden Orangemed, Inc.
Product code: Code MNT
Device class: Class 2
Regulation: 21 CFR 868.5895
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 ↗

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More clearances from Nihon Kohden Orangemed, Inc.

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K222644 — Nihon Kohden NKV-440 Ventilator System2023-05-31
K192307 — Nihon Kohden NKV-550 Series Ventilator System2020-01-10
K181695 — Nihon Kohden NKV-550 Series Ventilator System2018-12-07

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.