Cleared Traditional

Nitronox Scavenger Plus

K223452 · Parker Hannifin Corporation · Anesthesiology

Mar 2023

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K223452 is an FDA 510(k) clearance for the Nitronox Scavenger Plus, a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by Parker Hannifin Corporation (Hatfield, US). The FDA issued a Cleared decision on March 5, 2023, 110 days after receiving the submission on November 15, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number	K223452 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2022
Decision Date	March 05, 2023
Days to Decision	110 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF