The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Somatom Emotion 6 Ct Systems.
Device ID | K023687 |
510k Number | K023687 |
Device Name: | SOMATOM EMOTION 6 CT SYSTEMS |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS MEDICAL SYSTEMS, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Contact | Praveen Nadkarni |
Correspondent | Praveen Nadkarni SIEMENS MEDICAL SYSTEMS, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-01 |
Decision Date | 2002-11-22 |
Summary: | summary |