FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEVELERT II FLUID LEVEL SENSOR
K Number: K060123
·
Decision Feb 14, 2006
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
38
Applicant Total
529
Review Days
27
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Basic Information
- Device Name
- LEVELERT II FLUID LEVEL SENSOR
- K Number
- K060123
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- January 18, 2006
- Decision Date
- February 14, 2006
- Product Code
- FLN
- 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 |
|---|---|---|---|
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | FDA class 2 | General Hospital |
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