The following data is part of a premarket notification filed by Famidoc Technology Co., Ltd with the FDA for Infrared Thermometer.
| Device ID | K113761 |
| 510k Number | K113761 |
| Device Name: | INFRARED THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FAMIDOC TECHNOLOGY CO., LTD East 2/F,Zhixiang Building,71 BLOCK BAOAN DISTRICT Shenzhen, CN 518101 |
| Contact | Leon Cao |
| Correspondent | Leon Cao FAMIDOC TECHNOLOGY CO., LTD East 2/F,Zhixiang Building,71 BLOCK BAOAN DISTRICT Shenzhen, CN 518101 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-09-07 |
| Summary: | summary |