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 |