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ZetrOZ Systems, LLC

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories1
Latest FDA decision2026-04-28
TypeNumberDevice NameCodeDateActions
510(k) K260076 SAM 3.0 Multi-Hour Continuous Ultrasound DevicePFW2026-04-28 View
510(k) K233210 sam CS Long Duration Ultrasound DevicePFW2023-10-25 View
510(k) K223019 sam 2.0 Long Ultrasound DevicePFW2023-06-23 View
510(k) K211513 sam X1 Long Duration Ultrasound DevicePFW2021-08-18 View
510(k) K191568 sam 2.0 Long Duration Ultrasound SystemPFW2020-03-06 View
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