Cleared Traditional

Nihon Kohden NKV-550 Series Ventilator System

K192307 · Nihon Kohden Orangemed, Inc. · Anesthesiology
Jan 2020
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K192307 is an FDA 510(k) clearance for the Nihon Kohden NKV-550 Series Ventilator System, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Nihon Kohden Orangemed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 10, 2020, 137 days after receiving the submission on August 26, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K192307 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2019
Decision Date January 10, 2020
Days to Decision 137 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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