FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMIGO INSULIN PUMP
K Number: K071613
·
Decision Dec 14, 2007
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
82
Applicant Total
5
Review Days
184
Basic Information
- Device Name
- AMIGO INSULIN PUMP
- K Number
- K071613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIPRO DIABETES SYSTEMS, INC.
- Date Received
- June 13, 2007
- Decision Date
- December 14, 2007
- Product Code
- LZG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | FDA class 2 | General Hospital |
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Other Clearances by NIPRO DIABETES SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K050312 | AMIGO INSULIN PUMP | May 9, 2005 | Substantially Equivalent |
| K014114 | GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX | Jun 26, 2002 | Substantially Equivalent |
| K013309 | GLUCOPRO EVO INFUSION PUMP | Jun 24, 2002 | Substantially Equivalent |
| K011120 | GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES | May 8, 2001 | Substantially Equivalent |