The following data is part of a premarket notification filed by Medical Visors, Inc with the FDA for Medical Visors Mv100.
Device ID | K103507 |
510k Number | K103507 |
Device Name: | MEDICAL VISORS MV100 |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MEDICAL VISORS, INC 3834 ORCHID LANE SUITE B Calabasas, CA 91302 |
Contact | Brain Hughes |
Correspondent | Brain Hughes MEDICAL VISORS, INC 3834 ORCHID LANE SUITE B Calabasas, CA 91302 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-29 |
Decision Date | 2011-02-08 |
Summary: | summary |