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 |