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FDA 510(k) Applications Submitted by ZetrOZ Systems, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211513
05/14/2021
sam X1 Long Duration Ultrasound Device
ZetrOZ Systems, LLC
K191568
06/13/2019
sam 2.0 Long Duration Ultrasound System
ZetrOZ Systems, LLC
K223019
09/29/2022
sam 2.0 Long Ultrasound Device
ZetrOZ Systems, LLC
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