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FDA 510(k) Applications Submitted by ivWatch, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K222212
07/25/2022
ivWatch Model 400
ivWatch, LLC
K192385
09/03/2019
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
ivWatch, LLC
K162478
09/06/2016
ivWatch
ivWatch, LLC
K153605
12/17/2015
ivWatch Model 400
ivWatch, LLC
K142374
08/26/2014
ivWatch Model 400
ivWatch, LLC
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