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 |