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 |