The following data is part of a premarket notification filed by Vyaire Medical, Inc. with the FDA for Vyntus One With Cart, Vyntus One Pft Only With Cart, Vyntus One With Adjustable Cart, Vyntus One Pft Only With Adjustable Cart.
| Device ID | K181524 |
| 510k 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 |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | Vyaire Medical, Inc. Leibnizstrasse 7 Hoechber, DE 97204 |
| Contact | Elmar Niedermeyer |
| Correspondent | Elmar Niedermeyer Vyaire Medical, Inc. Leibnizstrasse 7 Hoechber, DE 97204 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892905600 | K181524 | 000 |
| 04250892904696 | K181524 | 000 |
| 14250892903894 | K181524 | 000 |
| 14250892903795 | K181524 | 000 |
| 14250892903580 | K181524 | 000 |
| 14250892903498 | K181524 | 000 |
| 34250892903188 | K181524 | 000 |
| 14250892903177 | K181524 | 000 |
| 14250892903160 | K181524 | 000 |
| 04250892905747 | K181524 | 000 |
| 14250892905904 | K181524 | 000 |
| 14250892904211 | K181524 | 000 |
| 04250892904702 | K181524 | 000 |
| 04250892904719 | K181524 | 000 |
| 04250892902661 | K181524 | 000 |
| 04250892902609 | K181524 | 000 |
| 04250892902593 | K181524 | 000 |
| 04250892902586 | K181524 | 000 |
| 04250892901084 | K181524 | 000 |
| 34250892903430 | K181524 | 000 |
| 34250892903423 | K181524 | 000 |
| 34250892903409 | K181524 | 000 |
| 14250892903269 | K181524 | 000 |
| 14250892904242 | K181524 | 000 |
| 04250892904733 | K181524 | 000 |
| 14250892903610 | K181524 | 000 |