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 | K133925 |
| 510k Number | K133925 |
| 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 | 2013-12-23 |
| Decision Date | 2014-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14250892903757 | K133925 | 000 |