The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Wrist Pulse Oximeter Md300w.
| Device ID | K081125 |
| 510k Number | K081125 |
| Device Name: | WRIST PULSE OXIMETER MD300W |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. ROOM 1127-1128 BUILDING B BAILANGYUAN FUXING RD. #A36 Beijing, CN 100041 |
| Contact | Lei Wang |
| Correspondent | Lei Wang BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. ROOM 1127-1128 BUILDING B BAILANGYUAN FUXING RD. #A36 Beijing, CN 100041 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2008-07-02 |
| Summary: | summary |