510(k) K212031
K212031 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare, Ltd. for the device "F&P 850 AirSpiral Adult NIV and NHF Circuit Kit". The FDA issued a decision of Substantially Equivalent on April 22, 2022. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Fisher & Paykel Healthcare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2022
- Date Received
- June 29, 2021
- 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