The following data is part of a premarket notification filed by Valeo Corp. with the FDA for Pacifier Thermometer Models Vt-901f, Vt901c.
| Device ID | K002562 |
| 510k Number | K002562 |
| Device Name: | PACIFIER THERMOMETER MODELS VT-901F, VT901C |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VALEO CORP. 501 SOUTH ANDREWS AVE. Ft. Lauderdale, FL 33301 |
| Contact | Marian Harding Cochran |
| Correspondent | Marian Harding Cochran VALEO CORP. 501 SOUTH ANDREWS AVE. Ft. Lauderdale, FL 33301 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-17 |
| Decision Date | 2000-10-13 |