The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for M-50 Series Spo2 Sensor.
| Device ID | K082487 |
| 510k Number | K082487 |
| Device Name: | M-50 SERIES SPO2 SENSOR |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. ROOM 1127-1128 BUILDING B BAILANGYUAN FUXING RD. #A36 Beijing, CN 100039 |
| Contact | Lei Chen |
| Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. ROOM 1127-1128 BUILDING B BAILANGYUAN FUXING RD. #A36 Beijing, CN 100039 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2009-03-04 |
| Summary: | summary |