MOBILETT MIRA
System, X-ray, Mobile
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 Mobilett Mira.
Pre-market Notification Details
| Device ID | K111912 |
| 510k Number | K111912 |
| Device Name: | MOBILETT MIRA |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-05 |
| Decision Date | 2011-09-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869009131 | K111912 | 000 |
Trademark Results [MOBILETT MIRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOBILETT MIRA 79100235 4078784 Live/Registered |
Siemens Healthcare GmbH 2011-06-16 |
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