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 | K130947 |
510k Number | K130947 |
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 | 2013-04-04 |
Decision Date | 2013-10-03 |
Summary: | summary |