The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artis Zee/zeego Sw Vc21.
Device ID | K141574 |
510k Number | K141574 |
Device Name: | ARTIS ZEE/ZEEGO SW VC21 |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Contact | Patricia D Jones |
Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Product Code | OWB |
Subsequent Product Code | IZI |
Subsequent Product Code | JAA |
Subsequent Product Code | JAK |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-12 |
Decision Date | 2014-09-05 |
Summary: | summary |