The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for Velox Nebulizer System.
| Device ID | K162785 |
| 510k Number | K162785 |
| Device Name: | Velox Nebulizer System |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI Respiratory Equipment, Inc. 2412 PARI Way Midlothian, VA 23112 |
| Contact | Michael Judge |
| Correspondent | Michael Judge PARI Respiratory Equipment, Inc. 2412 PARI Way Midlothian, VA 23112 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2017-04-14 |
| Summary: | summary |