The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Infrared Ear Themometer, Models Dx6603, Dx66390.
| Device ID | K051251 |
| 510k Number | K051251 |
| Device Name: | INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. 221 LONGCAO RD. SUITE 702, BLOCK 8, YUNDUXINYUAN GARDEN Shanghai, CN 200235 |
| Contact | Elvis Ge |
| Correspondent | Elvis Ge SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. 221 LONGCAO RD. SUITE 702, BLOCK 8, YUNDUXINYUAN GARDEN Shanghai, CN 200235 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-16 |
| Decision Date | 2005-09-07 |