The following data is part of a premarket notification filed by Vyaire Medical Inc. with the FDA for Vyntus Body.
| Device ID | K190853 |
| 510k Number | K190853 |
| Device Name: | Vyntus BODY |
| Classification | Calculator, Pulmonary Function Data |
| 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 | BZC |
| Subsequent Product Code | BTY |
| Subsequent Product Code | JEH |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-02 |
| Decision Date | 2019-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892904689 | K190853 | 000 |
| 04250892904672 | K190853 | 000 |
| 14250892905799 | K190853 | 000 |
| 04250892905693 | K190853 | 000 |
| 14250892903917 | K190853 | 000 |
| 14250892903900 | K190853 | 000 |
| 14250892903726 | K190853 | 000 |
| 04250892904863 | K190853 | 000 |