The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Sensation 64 And Sensation Cardiac.
| Device ID | K040665 |
| 510k Number | K040665 |
| Device Name: | SOMATOM SENSATION 64 AND SENSATION CARDIAC |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Nealie Hartmann |
| Correspondent | Nealie Hartmann SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-04 |
| Decision Date | 2004-04-02 |
| Summary: | summary |