The following data is part of a premarket notification filed by Paramed Srl with the FDA for Mrj.
Device ID | K033507 |
510k Number | K033507 |
Device Name: | MRJ |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | PARAMED SRL 719 CATALPA AVENUE Teaneck, NJ 07666 |
Contact | Diana Upton |
Correspondent | Diana Upton PARAMED SRL 719 CATALPA AVENUE Teaneck, NJ 07666 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-05 |
Decision Date | 2004-01-20 |