510(k) K193411
K193411 is an FDA 510(k) premarket notification submitted by Perma Pure, LLC for the device "O2asis Personal Oxygen Humidifier". The FDA issued a decision of Substantially Equivalent on Nov 12, 2020. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 12, 2020
- Date Received
- Dec 9, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type
- 510(k)