510(k) K231956
K231956 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare, Ltd. for the device "F&P Optiflow+ Duet Nasal Cannula". The FDA issued a decision of Substantially Equivalent on February 7, 2024. 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
- February 7, 2024
- Date Received
- July 3, 2023
- 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