The following data is part of a premarket notification filed by Vyaire Medical Inc with the FDA for Ltv2 Series Ventilators.
| Device ID | K201082 |
| 510k Number | K201082 |
| Device Name: | LTV2 Series Ventilators |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Vyaire Medical Inc 26125 N. Riverwoods Blvd. Mettawa, IL 60045 |
| Contact | Colleen Watson |
| Correspondent | Colleen Watson Vyaire Medical Inc 26125 N. Riverwoods Blvd. Mettawa, IL 60045 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-23 |
| Decision Date | 2021-11-10 |