YSIO MAX
System, X-ray, Stationary
SIEMENS MEDICAL SOLUTIONS USA, INC.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ysio Max.
Pre-market Notification Details
| Device ID | K133259 |
| 510k Number | K133259 |
| Device Name: | YSIO MAX |
| Classification | System, X-ray, Stationary |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Darren Dorman |
| Correspondent | Darren Dorman SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-23 |
| Decision Date | 2014-01-24 |
| Summary: | summary |
Trademark Results [YSIO MAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 YSIO MAX 79140428 4630395 Live/Registered |
Siemens Healthcare GmbH 2013-11-07 |
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