The following data is part of a premarket notification filed by Shenzhen Kingyield Technology Co., Ltd with the FDA for Finger Pulse Oximeter.
| Device ID | K123801 |
| 510k Number | K123801 |
| Device Name: | FINGER PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | SHENZHEN KINGYIELD TECHNOLOGY CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENZHEN KINGYIELD TECHNOLOGY CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-05-28 |
| Summary: | summary |