The following data is part of a premarket notification filed by Jxb Co. Ltd Guangzhou (china) with the FDA for Thermoflash Lx-26.
| Device ID | K080759 |
| 510k Number | K080759 |
| Device Name: | THERMOFLASH LX-26 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | JXB CO. LTD GUANGZHOU (CHINA) NO 38 HUANZHEN XI ROAD DAGANG TOWN Panuy, Guangzhou, CN |
| Contact | Tray Cui |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-05-12 |
| Summary: | summary |