FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
48 HOUR SET CHANGES
K Number: K842399
·
Decision Oct 9, 1984
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
29
Review Days
112
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Basic Information
- Device Name
- 48 HOUR SET CHANGES
- K Number
- K842399
- 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
- June 19, 1984
- Decision Date
- October 9, 1984
- 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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Other Clearances by Tri-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040112 | TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE | Mar 12, 2004 | Substantially Equivalent |
| K030877 | TRIMED RADIAL BULLET | Feb 5, 2004 | Substantially Equivalent |
| K010545 | TBW | Jun 6, 2001 | Substantially Equivalent |
| K961863 | PARACENTESIS TRAYS | May 28, 1996 | Substantially Equivalent |
| K875224 | HUDSON CRANINAL BURRS | Jan 28, 1988 | Substantially Equivalent |
| K850747 | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR | Apr 2, 1985 | Substantially Equivalent |
| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | Apr 2, 1985 | Substantially Equivalent |
| K850745 | TRI-MED MODEL 112 MOISTURE TRAP | Apr 2, 1985 | Substantially Equivalent |
| K843681 | RESPIRATION & HEART RATE MONITOR 530 | Dec 4, 1984 | Substantially Equivalent |
| K843285 | TRI-MED 610 CAPNOSTAT GAS ANALYZER | Nov 13, 1984 | Substantially Equivalent |