510(k) K223452
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