The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Somatom P30 Ct Systems.
Device ID | K013522 |
510k Number | K013522 |
Device Name: | SOMATOM P30 CT SYSTEMS |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS MEDICAL SYSTEMS, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Contact | Praveen Nadkarni |
Correspondent | Wolfram Gmelin TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2001-10-23 |
Decision Date | 2001-11-07 |
Summary: | summary |