Cleared Traditional

Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

K202480 · Parker Hannifin · Anesthesiology

Apr 2021

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K202480 is an FDA 510(k) clearance for the Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Parker Hannifin (Hatfield, US). The FDA issued a Cleared decision on April 22, 2021, 237 days after receiving the submission on August 28, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number	K202480 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2020
Decision Date	April 22, 2021
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF