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 |