K173060 is an FDA 510(k) clearance for the F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Fisher and Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on January 25, 2018, 119 days after receiving the submission on September 28, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K173060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2017 |
| Decision Date | January 25, 2018 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK - Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |