The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Ysio Max.
Device ID | K181279 |
510k Number | K181279 |
Device Name: | Ysio Max |
Classification | System, X-ray, Stationary |
Applicant | Siemens Medical Solutions, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
Contact | Denise Adams |
Correspondent | Denise Adams Siemens Medical Solutions, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-15 |
Decision Date | 2018-06-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
YSIO MAX 79140428 4630395 Live/Registered |
Siemens Healthcare GmbH 2013-11-07 |