Cleared Traditional

Nihon Kohden NKV-330 Ventilator System

K213521 · Nihon Kohden Orangemed, Inc. · Anesthesiology

Jul 2022

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K213521 is an FDA 510(k) clearance for the Nihon Kohden NKV-330 Ventilator System, a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II — Special Controls, product code MNT), submitted by Nihon Kohden Orangemed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 1, 2022, 240 days after receiving the submission on November 3, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K213521 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2021
Decision Date	July 01, 2022
Days to Decision	240 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5895