UROSKOP OMNIA
System, X-ray, Fluoroscopic, Image-intensified
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 Uroskop Omnia.
Pre-market Notification Details
| Device ID | K101491 |
| 510k Number | K101491 |
| Device Name: | UROSKOP OMNIA |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-01 |
| Decision Date | 2010-06-30 |
| Summary: | summary |
Trademark Results [UROSKOP OMNIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UROSKOP OMNIA 79085133 4010989 Live/Registered |
Siemens Healthcare GmbH 2010-06-10 |
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