FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
K Number: K071884
·
Decision Aug 9, 2007
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
78
Applicant Total
13
Review Days
31
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Basic Information
- Device Name
- BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
- K Number
- K071884
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jawon Medical Co., Ltd.
- Date Received
- July 9, 2007
- Decision Date
- August 9, 2007
- 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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Other Clearances by Jawon Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K092432 | AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) | Oct 9, 2009 | Substantially Equivalent |
| K092431 | BODY COMPOSITION ANALYZER, MODEL: IOI 353 | Oct 8, 2009 | Substantially Equivalent |
| K072325 | BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 | Nov 30, 2007 | Substantially Equivalent |
| K062462 | NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L | Sep 29, 2006 | Substantially Equivalent |
| K053556 | BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 | Aug 31, 2006 | Substantially Equivalent |
| K013876 | INFRARED EAR THERMOMETER, MODEL DX-707 | Mar 4, 2002 | Substantially Equivalent |
| K002722 | DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 | Sep 11, 2000 | Substantially Equivalent |
| K000675 | MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 | Mar 14, 2000 | Substantially Equivalent |