FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURESET 3.0 ML RESERVOIR, MODEL 24-103
K Number: K024056
·
Decision Jan 17, 2003
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
3
Review Days
39
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Basic Information
- Device Name
- SURESET 3.0 ML RESERVOIR, MODEL 24-103
- K Number
- K024056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Diabetes Research, Incorporated
- Date Received
- December 9, 2002
- Decision Date
- January 17, 2003
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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