The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Sentrysuite Product Line.
| Device ID | K113813 |
| 510k Number | K113813 |
| Device Name: | SENTRYSUITE PRODUCT LINE |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| 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 | BTY |
| Subsequent Product Code | BZC |
| Subsequent Product Code | BZG |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-05-10 |
| Summary: | summary |