The following data is part of a premarket notification filed by General Equipment For Medical Imaging with the FDA for Mammi.
| Device ID | K161631 |
| 510k Number | K161631 |
| Device Name: | MAMMI |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GENERAL EQUIPMENT FOR MEDICAL IMAGING EDUARDO PRIMO YUFERA, N 3 Valencia, ES 46012 |
| Contact | Jose Montes |
| Correspondent | Jose Montes GENERAL EQUIPMENT FOR MEDICAL IMAGING EDUARDO PRIMO YUFERA, N 3 Valencia, ES 46012 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2016-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437018413041 | K161631 | 000 |
| 08437018413034 | K161631 | 000 |