510(k) K223452

Nitronox Scavenger Plus by Parker Hannifin Corporation — Product Code CBN

K223452 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corporation for the device "Nitronox Scavenger Plus". The FDA issued a decision of Substantially Equivalent on March 5, 2023. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Parker Hannifin Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2023
Date Received
November 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type