510(k) K162553
K162553 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare for the device "AirSpiral Heated Breathing Tube". The FDA issued a decision of Substantially Equivalent on Dec 20, 2018. 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 has 74 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2018
- Date Received
- Sep 13, 2016
- 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)