The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Mammo M.
| Device ID | K882133 |
| 510k Number | K882133 |
| Device Name: | MAMMO M |
| Classification | System, X-ray, Mammographic |
| Applicant | ZIEHM INTERNATIONAL, INC. 4181 LATHAM ST. Riverside, CA 92501 |
| Contact | Wolfram H Klawitter |
| Correspondent | Wolfram H Klawitter ZIEHM INTERNATIONAL, INC. 4181 LATHAM ST. Riverside, CA 92501 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-20 |
| Decision Date | 1988-09-19 |