FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEDIATRIC IV WATCH
K Number: K852030
·
Decision May 30, 1985
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
97
Applicant Total
5
Review Days
22
Basic Information
- Device Name
- PEDIATRIC IV WATCH
- K Number
- K852030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- ALLTEK, INC.
- Date Received
- May 8, 1985
- Decision Date
- May 30, 1985
- 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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