Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900
FDA 510(k) K071884 · Jawon Medical Co., Ltd.
510(k) numberK071884
Submission
- Device name
- Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900
- Applicant
- Jawon Medical Co., Ltd.
Kyungsan-City, Kyungsan-Bukdo, KR - Received
- July 9, 2007
- Decision date
- August 9, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNW – Analyzer, Body Composition
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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More from Guangdong Transtek Medical Electronics Co., Ltd.
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| K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)DXN · Special | 10/09/2009SE |
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| K072325 | Body Composition Analyzer, Easybody 202, 203, 205MNW · Traditional | 11/30/2007SE |
| K062462 | Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LDXN · Traditional | 09/29/2006SE |
| K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5MNW · Traditional | 08/31/2006SE |
| K013876 | Infrared Ear Thermometer, Model DX-707FLL · Traditional | 03/04/2002SE |
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Questions and answers
When was Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900 cleared by the FDA?
Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900 (K071884) received a 510(k) decision of Substantially Equivalent on August 9, 2007, 31 days after the submission was received.
What is the product code of K071884?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.