510(k) K221014
K221014 is an FDA 510(k) premarket notification submitted by Effortless Oxygen, LLC for the device "Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile". The FDA issued a decision of Substantially Equivalent on October 17, 2022. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2022
- Date Received
- April 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conserver, Oxygen
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type