The following data is part of a premarket notification filed by Shine Overseas Marketing Limited with the FDA for Weight And Body Fat Scale Shine Bs0105.
Device ID | K112149 |
510k Number | K112149 |
Device Name: | WEIGHT AND BODY FAT SCALE SHINE BS0105 |
Classification | Analyzer, Body Composition |
Applicant | SHINE OVERSEAS MARKETING LIMITED 77325 JOYCE WAY Echo, OR 97826 |
Contact | Charlie Mack |
Correspondent | Charlie Mack SHINE OVERSEAS MARKETING LIMITED 77325 JOYCE WAY Echo, OR 97826 |
Product Code | MNW |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-26 |
Decision Date | 2012-04-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06970651384658 | K112149 | 000 |