The following data is part of a premarket notification filed by Vivalnk Inc. with the FDA for Fever Scout.
| Device ID | K181013 |
| 510k Number | K181013 |
| Device Name: | Fever Scout |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | VivaLnk Inc. 4655 Old Ironsides Drive, Suite 390 Santa Clara, CA 95054 |
| Contact | Christine Kuo |
| Correspondent | Christine Kuo VivaLnk Inc. 4655 Old Ironsides Drive, Suite 390 Santa Clara, CA 95054 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-17 |
| Decision Date | 2018-08-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FEVER SCOUT 86821968 5525244 Live/Registered |
VivaLnk 2015-11-16 |