The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Handheld Pulse Oximeter Model M800.
| Device ID | K101694 |
| 510k Number | K101694 |
| Device Name: | HANDHELD PULSE OXIMETER MODEL M800 |
| Classification | Oximeter |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-16 |
| Decision Date | 2010-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310058 | K101694 | 000 |