The following data is part of a premarket notification filed by Barkey Gmbh & Co. Kg with the FDA for Prismacomfort, Model Autocontrol 3xpt With Autoline Xpt 4r.
| Device ID | K071909 |
| 510k Number | K071909 |
| Device Name: | PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | BARKEY GMBH & CO. KG GEWERBESTRASSE 8 Leopoldshoehe, DE D-33818 |
| Contact | Thomas Barkey |
| Correspondent | Thomas Barkey BARKEY GMBH & CO. KG GEWERBESTRASSE 8 Leopoldshoehe, DE D-33818 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-11 |
| Decision Date | 2007-10-18 |
| Summary: | summary |