The following data is part of a premarket notification filed by Sfm Medical Devices Gmbh with the FDA for Nextaro Transfer System, Nextaro Va.
| Device ID | K183187 |
| 510k Number | K183187 |
| Device Name: | Nextaro Transfer System, Nextaro Va |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | SFM Medical Devices GmbH Brueckenstrasse 5 Waechtersbach Hessen, DE 63607 |
| Contact | Olaf Brömsen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-03-15 |