The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Modified Alpha Mc-9r C-arm.
| Device ID | K900967 |
| 510k Number | K900967 |
| Device Name: | MODIFIED ALPHA MC-9R C-ARM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Gerry L Buss |
| Correspondent | Gerry L Buss INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-05-09 |