FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BODY ANALYSIS SCALE, MODEL BG 17
K Number: K110928
·
Decision Jul 15, 2011
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
78
Applicant Total
3
Review Days
102
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Basic Information
- Device Name
- BODY ANALYSIS SCALE, MODEL BG 17
- K Number
- K110928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Healthcare Electronic Technology Co., Ltd.
- Date Received
- April 4, 2011
- Decision Date
- July 15, 2011
- 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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