The following data is part of a premarket notification filed by Bl Healthcare, Inc. with the FDA for Tcx-i-dv Remote Care Management System.
| Device ID | K093379 |
| 510k Number | K093379 |
| Device Name: | TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BL HEALTHCARE, INC. 33 COMMERCIAL ST., SUITE #3 Foxboro, MA 02035 |
| Contact | Michael Mathur |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2010-02-09 |
| Summary: | summary |