Vyaire Medical, Inc. · Class II · Cleared Nov 30, 2018
| K-number | K181524 |
| Device name | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART |
| Applicant | Vyaire Medical, Inc. |
| Product code | BZC |
| Device class | Class II |
| Decision date | Nov 30, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 868.1880 |
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