FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
K Number: K093379
·
Decision Feb 9, 2010
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
5
Review Days
103
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Basic Information
- Device Name
- TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
- K Number
- K093379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bl Healthcare, Inc.
- Date Received
- October 29, 2009
- Decision Date
- February 9, 2010
- Product Code
- KDI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Bl Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113493 | TCX-I REMOTE CARE MANAGEMENT SYSTEM | Dec 21, 2011 | Substantially Equivalent |
| K101078 | BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM | May 10, 2010 | Substantially Equivalent |
| K052608 | TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) | Feb 1, 2006 | Substantially Equivalent |
| K051470 | REMOTE CARE MANAGEMENT SYSTEMS (RCMS) | Jun 8, 2005 | Substantially Equivalent |