The following data is part of a premarket notification filed by Guangdong Long Yao Electronic Technology Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K201294 |
| 510k Number | K201294 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Guangdong Long Yao Electronic Technology Co., Ltd. Unit A03, 2nd Floor, No. 19, Huali Road, Tianhe District Guangzhou, CN 510000 |
| Contact | Lei Wang |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, 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 | 2020-05-14 |
| Decision Date | 2020-11-27 |