K200089 is an FDA 510(k) clearance for the F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on June 2, 2020, 139 days after receiving the submission on January 15, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K200089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2020 |
| Decision Date | June 02, 2020 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |