The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Vyntus / Sentrysuite Product Line.
| Device ID | K150810 |
| 510k Number | K150810 |
| Device Name: | Vyntus / SentrySuite Product Line |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg, DE 97204 |
| Contact | Elmar Niedermeyer |
| Correspondent | Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg, 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 | 2015-03-26 |
| Decision Date | 2015-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892904764 | K150810 | 000 |
| 14250892901227 | K150810 | 000 |
| 14250892901203 | K150810 | 000 |
| 34250892904963 | K150810 | 000 |
| 34250892904741 | K150810 | 000 |
| 34250892904758 | K150810 | 000 |
| 34250892903966 | K150810 | 000 |
| 34250892905656 | K150810 | 000 |
| 04250892904634 | K150810 | 000 |
| 04250892904627 | K150810 | 000 |
| 04250892904610 | K150810 | 000 |
| 04250892904603 | K150810 | 000 |
| 14250892903887 | K150810 | 000 |
| 14250892903641 | K150810 | 000 |
| 14250892904419 | K150810 | 000 |
| 34250892905816 | K150810 | 000 |
| 14250892903603 | K150810 | 000 |
| 14250892901319 | K150810 | 000 |
| 14250892901326 | K150810 | 000 |
| 04250892902036 | K150810 | 000 |
| 04250892901053 | K150810 | 000 |
| 34250892903386 | K150810 | 000 |
| 34250892902334 | K150810 | 000 |
| 34250892902327 | K150810 | 000 |
| 14250892904303 | K150810 | 000 |
| 14250892904297 | K150810 | 000 |
| 14250892904051 | K150810 | 000 |
| 14250892904044 | K150810 | 000 |
| 14250892904037 | K150810 | 000 |
| 14250892904013 | K150810 | 000 |
| 14250892903474 | K150810 | 000 |
| 14250892902552 | K150810 | 000 |
| 14250892901487 | K150810 | 000 |
| 14250892901449 | K150810 | 000 |
| 14250892901432 | K150810 | 000 |
| 34250892906066 | K150810 | 000 |