K162785 is an FDA 510(k) clearance for the Velox Nebulizer System. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on April 14, 2017, 193 days after receiving the submission on October 3, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K162785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2016 |
| Decision Date | April 14, 2017 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |