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 | K172141 |
| 510k Number | K172141 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shanghai Berry Electronic Tech Co., Ltd Unit C, 1st Floor, 7th Building, No. 1188 Lianhang Road Minhang District, Shanghai, CN 201112 |
| Contact | Xuezhi Yin |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, CN 102401 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-17 |
| Decision Date | 2018-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00897037001229 | K172141 | 000 |