510(k) K191568 ยท PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
sam 2.0 Long Duration Ultrasound System
| Applicant | ZetrOZ Systems, LLC, Trumbull CT, US |
| Decision | Substantially Equivalent, Mar 6, 2020 |
| Received | Jun 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191568
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.