The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Fingertip Pulse Oximeter.
| Device ID | K112804 |
| 510k Number | K112804 |
| Device Name: | FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2012-01-27 |
| Summary: | summary |