The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mammomat 300 And Mammomat 3000.
| Device ID | K932672 |
| 510k Number | K932672 |
| Device Name: | MAMMOMAT 300 AND MAMMOMAT 3000 |
| Classification | System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | George Katzebnbach |
| Correspondent | George Katzebnbach SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1994-09-14 |