The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siremobile C06.
| Device ID | K040066 |
| 510k Number | K040066 |
| Device Name: | SIREMOBILE C06 |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Nealie Hartman |
| Correspondent | Nealie Hartman SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-13 |
| Decision Date | 2004-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869009018 | K040066 | 000 |