ZetrOZ Systems, LLC FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
SAM 3.0 Multi-Hour Continuous Ultrasound Device510(k)Apr 28, 2026Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Apr 28, 2026
sam CS Long Duration Ultrasound Device510(k)Oct 25, 2023Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Oct 25, 2023
sam 2.0 Long Ultrasound Device510(k)Jun 23, 2023Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jun 23, 2023
sam X1 Long Duration Ultrasound Device510(k)Aug 18, 2021Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Aug 18, 2021