The following data is part of a premarket notification filed by Rio Flexon Technology Co., Ltd. with the FDA for Monitoring Ear Thermometer, Model Btm-d1a.
| Device ID | K062445 |
| 510k Number | K062445 |
| Device Name: | MONITORING EAR THERMOMETER, MODEL BTM-D1A |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RIO FLEXON TECHNOLOGY CO., LTD. 15F,868-2, JHONG JHENG RD., Jhonghe City Taipei County, TW 235 |
| Contact | Jeff Liao |
| Correspondent | Jeff Liao RIO FLEXON TECHNOLOGY CO., LTD. 15F,868-2, JHONG JHENG RD., Jhonghe City Taipei County, TW 235 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-22 |
| Decision Date | 2007-02-16 |
| Summary: | summary |