Fever Scout™ Continuous Monitoring Thermometer

Thermometer, Electronic, Clinical

VivaLnk Inc.

The following data is part of a premarket notification filed by Vivalnk Inc. with the FDA for Fever Scout™ Continuous Monitoring Thermometer.

Pre-market Notification Details

• Device ID: K162137
• 510k Number: K162137
• Device Name: Fever Scout™ Continuous Monitoring Thermometer
• Classification: Thermometer, Electronic, Clinical
• Applicant: VivaLnk Inc. 4655 Old Ironsides Dr. #390 Santa Clara, CA 95054
• Contact: Cecilia Xi
• Correspondent: Christine Kuo; VivaLnk Inc. 4655 Old Ironsides Dr. #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: 2016-08-01
• Decision Date: 2017-01-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00865064000164	K162137	000
00865064000119	K162137	000