The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Fingertip Pulse Oximeter Md300c.
| Device ID | K070371 |
| 510k Number | K070371 |
| Device Name: | FINGERTIP PULSE OXIMETER MD300C |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 8D ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE, 999 Shanghai, Shanghai, CN 20020 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUITE 8D ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE, 999 Shanghai, Shanghai, CN 20020 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782572433 | K070371 | 000 |
| 00616784709031 | K070371 | 000 |
| 00616784708836 | K070371 | 000 |
| 07540195054004 | K070371 | 000 |
| 10889483007532 | K070371 | 000 |
| B00500632CASE0 | K070371 | 000 |
| B005006320 | K070371 | 000 |