510(k) K180474
K180474 is an FDA 510(k) premarket notification submitted by Tni Medical AG for the device "TNI softFlow 50". The FDA issued a decision of Substantially Equivalent on Oct 18, 2018. 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
- Oct 18, 2018
- Date Received
- Feb 22, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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)