FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVI GUARDIAN MICRO 410 INFUSION PUMP
K Number: K843615
·
Decision Oct 31, 1984
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
13
Review Days
47
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Basic Information
- Device Name
- AVI GUARDIAN MICRO 410 INFUSION PUMP
- K Number
- K843615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Avi, Inc.
- Date Received
- September 14, 1984
- Decision Date
- October 31, 1984
- 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 |
| K854074 | MODEL 200 INFUSION PUMP | Dec 10, 1985 | Substantially Equivalent |
| K854073 | MODEL 210 INFUSION PUMP | Dec 10, 1985 | Substantially Equivalent |
| K843616 | AVI GUARDIAN 400 INFUSION PUMP | Oct 31, 1984 | Substantially Equivalent |