The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Fingertip Pulse Oximeters M70, M70a, M70b, M70c, M70d.
| Device ID | K151287 |
| 510k Number | K151287 |
| Device Name: | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D |
| Classification | Oximeter |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. INNOVATION FIRST ROAD TECHNOLOGY INNOVATION COAST Zhuhai, CN 519085 |
| Contact | Jin Liang |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-14 |
| Decision Date | 2016-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310256 | K151287 | 000 |
| 06932562310027 | K151287 | 000 |
| 06932562310010 | K151287 | 000 |
| 06932562310003 | K151287 | 000 |