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FDA 510(k) Applications for Medical Device Product Code "PMS"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K162478
ivWatch, LLC
ivWatch
12/22/2016
K153605
ivWatch, LLC
ivWatch Model 400
02/11/2016
K222212
ivWatch, LLC
ivWatch Model 400
08/24/2022
K192385
ivWatch, LLC
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
07/02/2020
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