ZetrOZ Systems, LLC

FDA Regulatory Profile

ZetrOZ Systems, LLC appears in FDA public data with 0 recalls, 5 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 28, 2026.

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceApril 28, 2026
K233210sam CS Long Duration Ultrasound DeviceOctober 25, 2023
K223019sam 2.0 Long Ultrasound DeviceJune 23, 2023
K211513sam X1 Long Duration Ultrasound DeviceAugust 18, 2021
K191568sam 2.0 Long Duration Ultrasound SystemMarch 6, 2020