The following data is part of a premarket notification filed by Zhuhai Linte Medical Instrument Co., Ltd. with the FDA for Fingertip Pulse Oximeter.
| Device ID | K210274 |
| 510k Number | K210274 |
| Device Name: | Fingertip Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Zhuhai Linte Medical Instrument Co., Ltd. 4th Floor, Building 1, No.66, Yongda Road, Hongqi Town, Jinwan District Zhuhai, CN 519090 |
| Contact | Kezheng Ma |
| 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 | 2021-02-01 |
| Decision Date | 2021-07-30 |