The following data is part of a premarket notification filed by Shanghai Berry Electronic Tech Co., Ltd with the FDA for Pulse Oximeter.
| Device ID | K142687 |
| 510k Number | K142687 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shanghai Berry Electronic Tech Co., Ltd Unit C, 1st Floor, 7th Building, No. 1188 Lianhang Road Shanghai, CN |
| Contact | Xuezhi Yin |
| Correspondent | Ray Wang Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Beijing, CN |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-04-13 |
| Summary: | summary |