The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mobilett Plus Mobile X-ray System.
Device ID | K932106 |
510k Number | K932106 |
Device Name: | MOBILETT PLUS MOBILE X-RAY SYSTEM |
Classification | System, X-ray, Mobile |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Contact | Kathleen Rutherford |
Correspondent | Kathleen Rutherford SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-03 |
Decision Date | 1994-09-14 |