510(k) K203449
K203449 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare, Ltd. for the device "F&P Visairo NIV Mask Range". The FDA issued a decision of Substantially Equivalent on Apr 14, 2021. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Fisher & Paykel Healthcare, Ltd. has 74 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 14, 2021
- Date Received
- Nov 23, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
- 510(k)