The following data is part of a premarket notification filed by Shenzhen Fitfaith Technology Co.,ltd with the FDA for Finger Pulse Oximeter.
| Device ID | K163135 |
| 510k Number | K163135 |
| Device Name: | Finger Pulse Oximeter |
| Classification | Oximeter |
| Applicant | SHENZHEN FITFAITH TECHNOLOGY CO.,LTD AREA B, FLOOR 9, BUILDING D1, TANGWEI INDUSTRIAL PARK, DONGLONG RD Guangming New District, Shenzhen, CN 518000 |
| Contact | Yuan Junfeng |
| Correspondent | Migo. Yang Shenzhen Joyantech Consulting Co., Ltd. 1122#, INTERNATION MAYOR COMMUNICATION CENTER, BAISHIZHONG RD 55#, Nanshan District, Shenzhen, CN 518000 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970953261305 | K163135 | 000 |
| 06970953261107 | K163135 | 000 |
| 06970953260049 | K163135 | 000 |
| 06970953260032 | K163135 | 000 |
| 06970953260025 | K163135 | 000 |
| 00851457007285 | K163135 | 000 |
| 20815991022634 | K163135 | 000 |