The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Arcadis Avantic.
Device ID | K051133 |
510k Number | K051133 |
Device Name: | ARCADIS AVANTIC |
Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
Contact | Michael J Andrews |
Correspondent | Michael J Andrews SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-03 |
Decision Date | 2005-06-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869009001 | K051133 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ARCADIS AVANTIC 79011364 3083079 Live/Registered |
Siemens Healthcare GmbH 2005-05-06 |