The following data is part of a premarket notification filed by Bl Healthcare, Inc. with the FDA for Bl Healthcare Remote Care Management System.
| Device ID | K101078 |
| 510k Number | K101078 |
| Device Name: | BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | BL HEALTHCARE, INC. 33 COMMERCIAL ST., SUITE #3 Foxboro, MA 02035 |
| Contact | Michael Mathur |
| Correspondent | Michael Mathur BL HEALTHCARE, INC. 33 COMMERCIAL ST., SUITE #3 Foxboro, MA 02035 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2010-05-10 |
| Summary: | summary |