FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
IMPEDIMED - BODY COMPOSITION ANALYSIS
K Number: K050395
·
Decision Jul 13, 2005
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
78
Applicant Total
4
Review Days
147
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Basic Information
- Device Name
- IMPEDIMED - BODY COMPOSITION ANALYSIS
- K Number
- K050395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Impedimed Pty , Ltd.
- Date Received
- February 16, 2005
- Decision Date
- July 13, 2005
- Product Code
- MNW
- 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 |
|---|---|---|---|
| MNW | Analyzer, Body Composition | FDA class 2 | Cardiovascular |
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