The following data is part of a premarket notification filed by Valeo Corp. with the FDA for Clinical Electronic Thermometer.
| Device ID | K982140 |
| 510k Number | K982140 |
| Device Name: | CLINICAL ELECTRONIC THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VALEO CORP. 26792 VIA ALCALA Mission Viejo, CA 92691 -3432 |
| Contact | Phil Zulueta |
| Correspondent | Phil Zulueta VALEO CORP. 26792 VIA ALCALA Mission Viejo, CA 92691 -3432 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1998-12-08 |