The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd with the FDA for Electronic Thermometer.
| Device ID | K152739 |
| 510k Number | K152739 |
| Device Name: | Electronic Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD INNOVATION FIRST ROAD, TECHNOLOGY INNOVATION COAST Zhuhai, CN 519085 |
| Contact | Jing Liang |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-23 |
| Decision Date | 2016-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310041 | K152739 | 000 |
| 06932562310034 | K152739 | 000 |
| 04897087201019 | K152739 | 000 |