The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siremobil Compact.
| Device ID | K963093 |
| 510k Number | K963093 |
| Device Name: | SIREMOBIL COMPACT |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Kathy Rutherford |
| Correspondent | Kathy Rutherford SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-08 |
| Decision Date | 1996-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869008998 | K963093 | 000 |