The following data is part of a premarket notification filed by Shenzhen Imdk Medical Technology Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K173123 |
| 510k Number | K173123 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen IMDK Medical Technology Co., Ltd. C Zone, 10F, Building 16, Yuanshan Industrial B Area Gongming Street Guangming District, Shenzhen, CN |
| Contact | Xia Yuan |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square No. 18, Taizi Road Nanshan District, Shenzhen, CN 518067 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850632007536 | K173123 | 000 |
| 10891040702996 | K173123 | 000 |
| 50860002249655 | K173123 | 000 |