The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies, Llc with the FDA for Imagenmd.
Device ID | K041671 |
510k Number | K041671 |
Device Name: | IMAGENMD |
Classification | System, Tomography, Computed, Emission |
Applicant | CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC 200 N.E. MULBERRY Lee's Summit, MO 64086 |
Contact | Malinie Hasek |
Correspondent | Malinie Hasek CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC 200 N.E. MULBERRY Lee's Summit, MO 64086 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-21 |
Decision Date | 2004-07-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMAGENMD 78317579 2951476 Live/Registered |
Cardiovascular Imaging Technologies L.L.C. 2003-10-23 |