The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Modification To:fingertip Pulse Oximeter, Model Md300c Series.
| Device ID | K101577 |
| 510k Number | K101577 |
| Device Name: | MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2010-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782595326 | K101577 | 000 |
| 00634782063627 | K101577 | 000 |
| 00634782562854 | K101577 | 000 |
| 00634782562847 | K101577 | 000 |
| 00634782063023 | K101577 | 000 |
| 00634782561888 | K101577 | 000 |