The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Handheld Pulse Oximeter Model Md300a/ Md300k2/ Md300m.
| Device ID | K100203 |
| 510k Number | K100203 |
| Device Name: | HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 20030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 20030 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-05-17 |