The following data is part of a premarket notification filed by Zetroz Systems, Llc with the FDA for Sam X1 Long Duration Ultrasound Device.
| Device ID | K211513 |
| 510k Number | K211513 |
| Device Name: | Sam X1 Long Duration Ultrasound Device |
| Classification | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Applicant | ZetrOZ Systems, LLC 56 Quarry Road Trumbull, CT 06611 |
| Contact | Sabrina Lewis |
| Correspondent | Sabrina Lewis ZetrOZ Systems, LLC 56 Quarry Road Trumbull, CT 06611 |
| Product Code | PFW |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-14 |
| Decision Date | 2021-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857599005202 | K211513 | 000 |