Ivwatch, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233881ivWatch® Model 400March 15, 2024
K222212ivWatch Model 400August 24, 2022
K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableJuly 2, 2020
K162478ivWatchDecember 22, 2016
K153605ivWatch Model 400February 11, 2016
K142374ivWatch Model 400February 13, 2015