The following data is part of a premarket notification filed by Bl Healthcare, Inc. with the FDA for Telephone Based Bl Healthcare Remote Care Management System (rcms).
| Device ID | K052608 |
| 510k Number | K052608 |
| Device Name: | TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | BL HEALTHCARE, INC. 33 COMMERCIAL ST., SUITE #3 Foxboro, MA 02035 |
| Contact | Michael Mathur |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-22 |
| Decision Date | 2006-02-01 |
| Summary: | summary |