Medical Device Manufacturer · US , Trumbull , CT

ZetrOZ Systems, LLC - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2020

Recent clearances: SAM 3.0 Multi-Hour Continuous Ultrasound Device, sam CS Long Duration Ultrasound Device, sam 2.0 Long Ultrasound Device

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5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - ZetrOZ Systems, LLC Physical Medicine ✕

5 devices

1-5 of 5

Cleared Apr 28, 2026

SAM 3.0 Multi-Hour Continuous Ultrasound Device

Physical Medicine · 106d

Cleared Oct 25, 2023

sam CS Long Duration Ultrasound Device

Physical Medicine · 27d

Cleared Jun 23, 2023

sam 2.0 Long Ultrasound Device

Physical Medicine · 267d

Cleared Aug 18, 2021

sam X1 Long Duration Ultrasound Device

Physical Medicine · 96d

Cleared Mar 06, 2020

sam 2.0 Long Duration Ultrasound System

Physical Medicine · 267d