The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Minxray Hf80h High Frequency Diagnostic X-ray Unit.
| Device ID | K945707 |
| 510k Number | K945707 |
| Device Name: | MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT |
| Classification | System, X-ray, Mobile |
| Applicant | MINXRAY, INC. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Eith R Kretchmer |
| Correspondent | Eith R Kretchmer MINXRAY, INC. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-01-19 |