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ZetrOZ Systems, LLC
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
3
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K233210
sam CS Long Duration Ultrasound Device
October 25, 2023
K223019
sam 2.0 Long Ultrasound Device
June 23, 2023
K211513
sam X1 Long Duration Ultrasound Device
August 18, 2021
K191568
sam 2.0 Long Duration Ultrasound System
March 6, 2020