The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Body Composition Analyzer, Model: Ioi 353.
| Device ID | K092431 |
| 510k Number | K092431 |
| Device Name: | BODY COMPOSITION ANALYZER, MODEL: IOI 353 |
| 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 | H L Jung MI CONSULTING CO., LTD. ROOM 431, 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 | 2009-08-07 |
| Decision Date | 2009-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08805116000164 | K092431 | 000 |