The following data is part of a premarket notification filed by Jawon Medical Co., Ltd. with the FDA for Body Composition Analyzer.
| Device ID | K140045 |
| 510k Number | K140045 |
| Device Name: | BODY COMPOSITION ANALYZER |
| Classification | Analyzer, Body Composition |
| Applicant | JAWON MEDICAL CO., LTD. #1208-12, Sinsang-Li, Jinryang-Myun Kyungsan-city, Kyungsan-bukdo, KR 712-830 |
| Contact | W S Park |
| Correspondent | W S Park MEDMONTS CO., LTD LIFE-OFFICETEL 320,40,63-RO YOUNGDEUNGPO-GU Seoul, 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 | 2014-01-08 |
| Decision Date | 2015-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08805116000157 | K140045 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BODY COMPOSITION ANALYZER 76007257 not registered Dead/Abandoned |
RxFiles.Net Corporation, The 2000-03-22 |
![]() BODY COMPOSITION ANALYZER 75889114 not registered Dead/Abandoned |
The RxFiles.Net Corporation 2000-01-06 |