Tcx-I Remote Care Management System
FDA 510(k) K113493 · Bl Healthcare, Inc.
510(k) numberK113493
Submission
- Device name
- Tcx-I Remote Care Management System
- Applicant
- Bl Healthcare, Inc.
Foxboro, MA, US - Received
- November 25, 2011
- Decision date
- December 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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More from Cardioline S.P.A
| 510(k) | Device | Decision |
|---|---|---|
| K101078 | BL Healthcare Remote Care Management SystemDRG · Special | 05/10/2010SE |
| K093379 | Tcx-I-Dv Remote Care Management SystemKDI · Traditional | 02/09/2010SE |
| K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS)DRG · Traditional | 02/01/2006SE |
| K051470 | Remote Care Management Systems (RCMS)DRG · Traditional | 06/08/2005SE |
Questions and answers
When was Tcx-I Remote Care Management System cleared by the FDA?
Tcx-I Remote Care Management System (K113493) received a 510(k) decision of Substantially Equivalent on December 21, 2011, 26 days after the submission was received.
What is the product code of K113493?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.