The following data is part of a premarket notification filed by Denterprise International, Inc. with the FDA for Mobilex Portable X-ray System.
| Device ID | K180561 |
| 510k Number | K180561 |
| Device Name: | MobileX Portable X-ray System |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Denterprise International, Inc. 100 E. Granada Blvd., Suite 219 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Joyce St. Germain 510k FDA Consulting / Denterprise International, Inc. 100 E. Granada Blvd., Suite 219 Ormond Beach, FL 32176 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800060100144 | K180561 | 000 |