The following data is part of a premarket notification filed by Shenzhen Aeon Technology Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K200414 |
| 510k Number | K200414 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen Aeon Technology Co., Ltd. RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong No.133 Of Yiyuan Road, Nantou Street, Nanshan District Shenzhen, CN 518000 |
| Contact | Xie Hua |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park 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 | 2020-02-19 |
| Decision Date | 2020-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 36947832500429 | K200414 | 000 |
| 36947832500399 | K200414 | 000 |
| 16947832500470 | K200414 | 000 |