FDA 510(k)
FDA class 2
Unknown
🇦🇺 Australia
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
K Number: K080825
·
Decision Oct 3, 2008
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
4
Review Days
193
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Basic Information
- Device Name
- IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
- K Number
- K080825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Impedimed Pty , Ltd.
- Date Received
- March 24, 2008
- Decision Date
- October 3, 2008
- Product Code
- OBH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | FDA class 2 | Cardiovascular |
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