The following data is part of a premarket notification filed by Beijing Safe Heart Technology Ltd. with the FDA for Pulse Oximeter.
| Device ID | K172616 |
| 510k Number | K172616 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Beijing Safe Heart Technology Ltd. Room 101, Unit 6, Building NO.6 No.88 Kechuang 6th Street Beijing Economic-technological Developme, CN 101111 |
| Contact | Xiaoming Yang |
| Correspondent | Xiaoming Yang Beijing Safe Heart Technology Ltd. Room 101, Unit 6, Building NO.6 No.88 Kechuang 6th Street Beijing Economic-technological Developme, CN 101111 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2018-07-27 |
| Summary: | summary |