FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 200 INFUSION PUMP
K Number: K854074
·
Decision Dec 10, 1985
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
13
Review Days
67
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Basic Information
- Device Name
- MODEL 200 INFUSION PUMP
- K Number
- K854074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Avi, Inc.
- Date Received
- October 4, 1985
- Decision Date
- December 10, 1985
- 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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Other Clearances by Avi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882047 | ENTRUST(TM) MODEL 800 | Aug 11, 1988 | Substantially Equivalent |
| K875347 | MODEL 210A INFUSION PUMP | Apr 29, 1988 | Substantially Equivalent |
| K875348 | MODEL 400A INFUSION PUMP | Apr 29, 1988 | Substantially Equivalent |
| K875365 | MODEL 200A INFUSION PUMP | Apr 29, 1988 | Substantially Equivalent |
| K872515 | INFUSION PUMP MODEL 470 | Dec 16, 1987 | Substantially Equivalent |
| K872514 | INFUSION PUMP MODEL 270 | Dec 16, 1987 | Substantially Equivalent |
| K872516 | INFUSION PUMP MODEL 275 | Dec 16, 1987 | Substantially Equivalent |
| K854073 | MODEL 210 INFUSION PUMP | Dec 10, 1985 | Substantially Equivalent |
| K843616 | AVI GUARDIAN 400 INFUSION PUMP | Oct 31, 1984 | Substantially Equivalent |
| K843615 | AVI GUARDIAN MICRO 410 INFUSION PUMP | Oct 31, 1984 | Substantially Equivalent |