The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Minxray Hf70d High Frequency Portable Dental X-ray Unit.
| Device ID | K000061 |
| 510k Number | K000061 |
| Device Name: | MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | MINXRAY, INC. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Keith Kretchmer |
| Correspondent | Keith Kretchmer MINXRAY, INC. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-10 |
| Decision Date | 2000-04-07 |