K083832 is an FDA 510(k) clearance for the ZEST NASAL MASK. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Fisher &Paykel Healthcare , Ltd. (East Tamaki, NZ). The FDA issued a Cleared decision on March 16, 2009, 83 days after receiving the submission on December 23, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K083832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2008 |
| Decision Date | March 16, 2009 |
| Days to Decision | 83 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 |