The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Fingertip Pulse Oximeter Md300cg11/md300cg51.
Device ID | K160268 |
510k Number | K160268 |
Device Name: | Fingertip Pulse Oximeter MD300CG11/MD300CG51 |
Classification | Oximeter |
Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. NO.9 SHUANGYUAN ROAD BADACHU HI-TECH ZONE, SHIJINGSHAN DISTRICT Beijing, CN 100041 |
Contact | Lei Chen |
Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. NO.9 SHUANGYUAN ROAD BADACHU HI-TECH ZONE, SHIJINGSHAN DISTRICT Beijing, CN 100041 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-02 |
Decision Date | 2016-10-14 |
Summary: | summary |