The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Mobilette Xp And Mobilett Xphybrid.
| Device ID | K033238 |
| 510k Number | K033238 |
| Device Name: | MOBILETTE XP AND MOBILETT XPHYBRID |
| Classification | System, X-ray, Mobile |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Contact | Nealie Hartman |
| Correspondent | Nealie Hartman SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY 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 | 2003-10-06 |
| Decision Date | 2003-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869009094 | K033238 | 000 |
| 04056869009087 | K033238 | 000 |