The following data is part of a premarket notification filed by Xilas Medical, Inc. with the FDA for Temptouch Dermal Thermometer.
| Device ID | K050137 |
| 510k Number | K050137 |
| Device Name: | TEMPTOUCH DERMAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | XILAS MEDICAL, INC. 12665 SILICON DR. San Antonio, TX 78249 -3412 |
| Contact | Ruben G Zamorano |
| Correspondent | Silvia Ankova UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-24 |
| Decision Date | 2005-03-18 |