The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artiste Mv Sa.
Device ID | K072485 |
510k Number | K072485 |
Device Name: | ARTISTE MV SA |
Classification | Accelerator, Linear, Medical |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 16787 BERNARDO CENTER DRIVE San Diego, CA 92128 |
Contact | Erik Rodriguez |
Correspondent | Erik Rodriguez SIEMENS MEDICAL SOLUTIONS USA, INC. 16787 BERNARDO CENTER DRIVE San Diego, CA 92128 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-04 |
Decision Date | 2007-12-27 |
Summary: | summary |