The following data is part of a premarket notification filed by Shenzhen Yimi Life-technology Co.,ltd. with the FDA for Pulse Oximeter.
Device ID | K191430 |
510k Number | K191430 |
Device Name: | Pulse Oximeter |
Classification | Oximeter |
Applicant | Shenzhen Yimi Life-Technology Co.,Ltd. 305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village, Pingshan Shenzhen, CN 518118 |
Contact | Shande Peng |
Correspondent | Shande Peng Shenzhen Yimi Life-Technology Co.,Ltd. 305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village, Pingshan Shenzhen, CN 518118 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-29 |
Decision Date | 2019-10-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06972911370043 | K191430 | 000 |
10859020006151 | K191430 | 000 |
00628055787440 | K191430 | 000 |
10628055787454 | K191430 | 000 |
00859811009258 | K191430 | 000 |
06972911370005 | K191430 | 000 |
06972911370012 | K191430 | 000 |
06972911370029 | K191430 | 000 |
06972911370036 | K191430 | 000 |
00382098017062 | K191430 | 000 |