The following data is part of a premarket notification filed by Dongguan Lingxin Technologies Co., Ltd with the FDA for Pulse Oximeter.
| Device ID | K210305 |
| 510k Number | K210305 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Dongguan Lingxin Technologies Co., LTD Room 301, No. 3 Liantang Road, Aoshitang, Dongcheng Street Dongguan, CN 523129 |
| Contact | Cony Tang |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Mangement Consulting., Ltd Room 1813 Of Gebu Commercial Building, Hongxing, Songgang Street, Baoan 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 | 2021-02-03 |
| Decision Date | 2021-12-22 |