510(k) K211513 ยท PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
sam X1 Long Duration Ultrasound Device
| Applicant | ZetrOZ Systems, LLC, Trumbull CT, US |
| Decision | Substantially Equivalent, Aug 18, 2021 |
| Received | May 14, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211513
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.