The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Masterad Mx30.
| Device ID | K190601 |
| 510k Number | K190601 |
| Device Name: | MasteRad MX30 |
| Classification | System, X-ray, Stationary |
| Applicant | MedicaTech USA 50 Maxwell Irvine, CA 92618 |
| Contact | George Makar |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-08 |
| Decision Date | 2019-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001404753 | K190601 | 000 |