The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Micro-fine High Freq. Mobile Mammo. System Mf-150.
| Device ID | K885135 |
| 510k Number | K885135 |
| Device Name: | MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150 |
| Classification | System, X-ray, Mammographic |
| Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
| Contact | Howard Rosenberg |
| Correspondent | Howard Rosenberg BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-15 |
| Decision Date | 1989-03-09 |