FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVFLO-HP & IVFIL-HP FILTER
K Number: K831350
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
29
Review Days
109
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Basic Information
- Device Name
- IVFLO-HP & IVFIL-HP FILTER
- K Number
- K831350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Tri-Med, Inc.
- Date Received
- April 25, 1983
- Decision Date
- August 12, 1983
- Product Code
- FPB
- 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | FDA class 2 | General Hospital |
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| K875224 | HUDSON CRANINAL BURRS | Jan 28, 1988 | Substantially Equivalent |
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| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | Apr 2, 1985 | Substantially Equivalent |
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| K843681 | RESPIRATION & HEART RATE MONITOR 530 | Dec 4, 1984 | Substantially Equivalent |
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