The following data is part of a premarket notification filed by Valeo Corp. with the FDA for Valeo Vt-601 Series Ir Thermometer.
| Device ID | K111463 |
| 510k Number | K111463 |
| Device Name: | VALEO VT-601 SERIES IR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VALEO CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich VALEO CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-26 |
| Decision Date | 2012-02-17 |
| Summary: | summary |