The following data is part of a premarket notification filed by Imt America, Inc. with the FDA for Mthf-9s Mobil C-arm Image Intensifier Unit.
| Device ID | K900194 |
| 510k Number | K900194 |
| Device Name: | MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | IMT AMERICA, INC. 120 EAST BALTIMORE ST. Baltimore, MD 21202 |
| Contact | Peggy Chaplin |
| Correspondent | Peggy Chaplin IMT AMERICA, INC. 120 EAST BALTIMORE ST. Baltimore, MD 21202 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-16 |
| Decision Date | 1990-05-07 |