The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Model Mgb-301 Diaphragm Film 24 X 30 Cm.
| Device ID | K912180 |
| 510k Number | K912180 |
| Device Name: | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM |
| Classification | Collimator, Manual, Radiographic |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Edward R Barker |
| Correspondent | Edward R Barker INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Product Code | IZX |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-10-21 |