510(k) K182454
K182454 is an FDA 510(k) premarket notification submitted by O2 Concepts, LLC for the device "O2 Concepts Oxlife Independence Model 301-0001". The FDA issued a decision of Substantially Equivalent on Dec 20, 2018. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2018
- Date Received
- Sep 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type
- 510(k)