The following data is part of a premarket notification filed by Bl Healthcare, Inc. with the FDA for Tcx-i Remote Care Management System.
| Device ID | K113493 |
| 510k Number | K113493 |
| Device Name: | TCX-I REMOTE CARE MANAGEMENT SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | BL HEALTHCARE, INC. 33 COMMERCIAL ST., SUITE #3 Foxboro, MA 02035 |
| Contact | Micheal Mathur |
| Correspondent | Micheal Mathur BL HEALTHCARE, INC. 33 COMMERCIAL ST., SUITE #3 Foxboro, MA 02035 |
| Product Code | DRG |
| Subsequent Product Code | BZH |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DQD |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GJS |
| Subsequent Product Code | LFR |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-25 |
| Decision Date | 2011-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863353000307 | K113493 | 000 |