FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
K Number: K052608
·
Decision Feb 1, 2006
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
5
Review Days
132
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Basic Information
- Device Name
- TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
- K Number
- K052608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bl Healthcare, Inc.
- Date Received
- September 22, 2005
- Decision Date
- February 1, 2006
- Product Code
- DRG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
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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 |
| K093379 | TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM | Feb 9, 2010 | Substantially Equivalent |
| K051470 | REMOTE CARE MANAGEMENT SYSTEMS (RCMS) | Jun 8, 2005 | Substantially Equivalent |