The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Vyntus Walk.
| Device ID | K142959 |
| 510k Number | K142959 |
| Device Name: | Vyntus Walk |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2015-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54250892904899 | K142959 | 000 |
| 54250892905711 | K142959 | 000 |