FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FINESSE PERSONAL INSULIN DELIVERY PATCH
K Number: K111924
·
Decision Apr 10, 2012
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
3
Review Days
279
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Basic Information
- Device Name
- FINESSE PERSONAL INSULIN DELIVERY PATCH
- K Number
- K111924
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Calibra Medical, Inc.
- Date Received
- July 6, 2011
- Decision Date
- April 10, 2012
- Product Code
- OPP
- 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 |
|---|---|---|---|
| OPP | Pump, Infusion, Insulin Bolus | FDA class 2 | General Hospital |
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