The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Body Composition Analyzer, Models: X-scan Plus Ii, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900.
| Device ID | K071884 |
| 510k Number | K071884 |
| Device Name: | BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 |
| Classification | Analyzer, Body Composition |
| Applicant | JAWON MEDICAL CO., LTD. #1208-12, Sinsang-Li, Jinryang-Myun Kyungsan-city, Kyungsan-bukdo, KR 712-830 |
| Contact | Won-hee Park |
| Correspondent | Hl Jung MI Consulting Co., Ltd. ROOM 624, LIFE OFFICETEL, 61-3 YOIDO-DONG, YOUNGDEUNGPO-GU Seoul, Korea, KR 150-731 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-09 |
| Decision Date | 2007-08-09 |
| Summary: | summary |