FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
K Number: K013782
·
Decision Nov 20, 2001
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
17
Review Days
6
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Basic Information
- Device Name
- DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
- K Number
- K013782
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Disetronic Medical Systems
- Date Received
- November 14, 2001
- Decision Date
- November 20, 2001
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Disetronic Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K994186 | DISETRONIC D-TRON INSULIN INFUSION PUMP | Dec 30, 1999 | Substantially Equivalent |
| K994197 | DISENTRONIC PENFINE INJECTION PEN NEEDLE | Dec 29, 1999 | Substantially Equivalent |
| K993666 | DISETRONIC PEN P100 | Nov 22, 1999 | Substantially Equivalent |
| K991376 | DAHEDI INSULIN INFUSION PUMP | Jun 15, 1999 | Substantially Equivalent |
| K990259 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | Feb 12, 1999 | Substantially Equivalent |
| K982966 | DISETRONIC PEN | Oct 19, 1998 | Substantially Equivalent |
| K982399 | DISETRONIC PENFINE INJECTION PEN NEEDLE | Aug 6, 1998 | Substantially Equivalent |
| K973339 | DISETRONIC PENFINE INJECTION PEN NEEDLE | Sep 24, 1997 | Substantially Equivalent |
| K973044 | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP | Sep 15, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K961975 | DISETRONIC D-MODEM | Jan 30, 1997 | Substantially Equivalent - Subject to Tracking Reg. |