The following data is part of a premarket notification filed by Shenzhen Greatmade Tech Limited with the FDA for Oximeter.
Device ID | K173045 |
510k Number | K173045 |
Device Name: | Oximeter |
Classification | Oximeter |
Applicant | Shenzhen Greatmade Tech Limited 3th Floor, B Building, BaiFuli Industrial Zone ShangHengLang, HuaHui Road Shenzhen, CN |
Contact | Mei Mei |
Correspondent | Mei Mei Shenzhen Greatmade Tech Limited 3th Floor, B Building, BaiFuli Industrial Zone ShangHengLang, HuaHui Road Shenzhen, CN |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-28 |
Decision Date | 2018-06-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OXIMETER 86730853 not registered Dead/Abandoned |
Pearl Enterprises LLC 2015-08-20 |