The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Body Composition Analyzer, Easybody 202, 203, 205.
Device ID | K072325 |
510k Number | K072325 |
Device Name: | BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-20 |
Decision Date | 2007-11-30 |
Summary: | summary |