The following data is part of a premarket notification filed by Zetroz Systems, Llc with the FDA for Sam 2.0 Long Duration Ultrasound System.
| Device ID | K191568 |
| 510k Number | K191568 |
| Device Name: | Sam 2.0 Long Duration Ultrasound System |
| 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 Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | PFW |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2020-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857599005196 | K191568 | 000 |
| 00857599005165 | K191568 | 000 |
| 00857599005172 | K191568 | 000 |