The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Koordinat M.
Device ID | K951176 |
510k Number | K951176 |
Device Name: | KOORDINAT M |
Classification | Table, Radiographic, Tilting |
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 | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-15 |
Decision Date | 1995-04-20 |