The following data is part of a premarket notification filed by Visiomed Group Sa with the FDA for Thermoflash(tm) Infrared Thermometer.
| Device ID | K112929 |
| 510k Number | K112929 |
| Device Name: | THERMOFLASH(TM) INFRARED THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VISIOMED GROUP SA 21, AVENUE VICTOR HUGE Paris, FR 75116 |
| Contact | Eric Sebban |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-10-18 |
| Summary: | summary |