510(k) K222086
K222086 is an FDA 510(k) premarket notification submitted by Inogen for the device "Inogen Rove 4 Portable Oxygen Concentrator". The FDA issued a decision of Substantially Equivalent on December 9, 2022. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Inogen has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2022
- Date Received
- July 15, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type