The following data is part of a premarket notification filed by Rio Flexon Technology Co., Ltd. with the FDA for Wireless Body Temperature Monitor, Models Btm-dic, D, E, F, G And H.
| Device ID | K081256 |
| 510k Number | K081256 |
| Device Name: | WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND 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 | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-02 |
| Decision Date | 2008-05-27 |
| Summary: | summary |