The following data is part of a premarket notification filed by Medical Device Marketing Network, Inc. with the FDA for Giotto Mammography Hf.
| Device ID | K901558 |
| 510k Number | K901558 |
| Device Name: | GIOTTO MAMMOGRAPHY HF |
| Classification | System, X-ray, Mammographic |
| Applicant | MEDICAL DEVICE MARKETING NETWORK, INC. P.O. BOX 5206 Cleveland, OH 44095 -0206 |
| Contact | John Perez |
| Correspondent | John Perez MEDICAL DEVICE MARKETING NETWORK, INC. P.O. BOX 5206 Cleveland, OH 44095 -0206 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1990-07-03 |