The following data is part of a premarket notification filed by Beijing Rongrui-century Scie. & Tech. Co., Ltd. with the FDA for Pulse Oximeter Sensor (disposable And Reusable) Model Rsa002dn, Rsj002da, Rsj091di, Rst063ca.
| Device ID | K103685 |
| 510k Number | K103685 |
| Device Name: | PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA |
| Classification | Oximeter |
| Applicant | BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. P.O. BOX 237-023 Shangahi, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. P.O. BOX 237-023 Shangahi, CN 200237 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-17 |
| Decision Date | 2011-07-15 |
| Summary: | summary |