510(k) K223452
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