The following data is part of a premarket notification filed by Rio Flexon Technology Co., Ltd. with the FDA for Wireless Body Temperature Monitor Model Btm-dix Series (btm-dic,d,e,f,g & H).
| Device ID | K100226 |
| 510k Number | K100226 |
| Device Name: | WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RIO FLEXON TECHNOLOGY CO., LTD. 15F,868-2, JHONG JHENG RD., Jhonghe City Taipei County, TW 235 |
| Contact | Chi-hung Liao |
| Correspondent | Chi-hung 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-03-18 |
| Summary: | summary |