The following data is part of a premarket notification filed by Paramed Srl with the FDA for Multiarray Kit.
Device ID | K121249 |
510k Number | K121249 |
Device Name: | MULTIARRAY KIT |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | PARAMED SRL CORSO PERRONE 73R Genova, IT 16152 |
Contact | Luisella De Benedetti |
Correspondent | Luisella De Benedetti PARAMED SRL CORSO PERRONE 73R Genova, IT 16152 |
Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-25 |
Decision Date | 2012-06-12 |
Summary: | summary |