The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Fingertip Pulse Oximeter.
Device ID | K151206 |
510k Number | K151206 |
Device Name: | Fingertip Pulse Oximeter |
Classification | Oximeter |
Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO. 9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE SHIJINGSHAN DISTRICT Beijing, CN 100041 |
Contact | Lei Chen |
Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOLGY 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 | 2015-05-06 |
Decision Date | 2015-08-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10875011000038 | K151206 | 000 |