The following data is part of a premarket notification filed by Vyaire Medical with the FDA for Airlife Adult Heated Wire Bipap/niv Circuit.
| Device ID | K170378 |
| 510k Number | K170378 |
| Device Name: | AirLife Adult Heated Wire BiPAP/NIV Circuit |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | Vyaire Medical 75 North Fairway Drive Vernon Hills, IL 60061 |
| Contact | Sharon Nichols |
| Correspondent | Colleen Watson (o'keeffe) Vyaire Medical 75 North Fairway Drive Vernon Hills, IL 60061 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-07 |
| Decision Date | 2017-09-14 |
| Summary: | summary |