The following data is part of a premarket notification filed by Del Medical, Inc. with the FDA for Mdr17 Mobile Direct Radiographic System.
| Device ID | K173018 |
| 510k Number | K173018 |
| Device Name: | MDR17 Mobile Direct Radiographic System |
| Classification | System, X-ray, Mobile |
| Applicant | Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 |
| Contact | Tony Bavuso |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858340006004 | K173018 | 000 |