The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Fingertip Pulse Oximeter, Model M70, And Handheld Pulse Oximeter, Model M700.
| Device ID | K081712 |
| 510k Number | K081712 |
| Device Name: | FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 |
| Classification | Oximeter |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. ZHONGSHAN NO. 2 RD., LN 999 SUITE 8D, NO. 19 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD. ZHONGSHAN NO. 2 RD., LN 999 SUITE 8D, NO. 19 Shanghai, CN 200030 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310065 | K081712 | 000 |