The following data is part of a premarket notification filed by Vyaire Medical with the FDA for Vyntus/sentrysuite Product Line.
| Device ID | K183567 |
| 510k Number | K183567 |
| Device Name: | Vyntus/SentrySuite Product Line |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | Vyaire Medical Leibnizstrasse 7 Hoechberg, DE 97204 |
| Contact | Elmar Niedermeyer |
| Correspondent | Elmar Niedermeyer Vyaire Medical Leibnizstrasse 7 Hoechberg, DE 97204 |
| Product Code | BZC |
| Subsequent Product Code | DPS |
| Subsequent Product Code | MLC |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34250892903973 | K183567 | 000 |
| 04250892905891 | K183567 | 000 |
| 14250892905416 | K183567 | 000 |
| 04250892905914 | K183567 | 000 |
| 04250892905839 | K183567 | 000 |
| 34250892905861 | K183567 | 000 |
| 34250892905878 | K183567 | 000 |
| 04250892905709 | K183567 | 000 |
| 14250892904020 | K183567 | 000 |
| 14250892904570 | K183567 | 000 |
| 04250892905945 | K183567 | 000 |