The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Fingertip Pulse Oximeter, Model Md300ca Nd300ca.
| Device ID | K092652 |
| 510k Number | K092652 |
| Device Name: | FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. BAILANGUYAN BLDG B 1127-1128 FUXING RD, A36 Beijing, CN 100039 |
| Contact | Lei Chen |
| Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. BAILANGUYAN BLDG B 1127-1128 FUXING RD, A36 Beijing, CN 100039 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-28 |
| Decision Date | 2010-01-08 |
| Summary: | summary |