The following data is part of a premarket notification filed by Mrx Corp. with the FDA for Mrx-280.
Device ID | K942040 |
510k Number | K942040 |
Device Name: | MRX-280 |
Classification | System, X-ray, Tomography, Computed |
Applicant | MRX CORP. 320 WESTWAY PL., SUITE 520 Arlington, TX 76018 |
Contact | Mitch Jensen |
Correspondent | Mitch Jensen MRX CORP. 320 WESTWAY PL., SUITE 520 Arlington, TX 76018 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-28 |
Decision Date | 1994-07-05 |