The following data is part of a premarket notification filed by Minxray, Inc with the FDA for Tr90bh.
| Device ID | K182207 |
| 510k Number | K182207 |
| Device Name: | TR90BH |
| Classification | System, X-ray, Mobile |
| Applicant | MinXray, Inc 3611 Commercial Ave Northbrook, IL 60062 |
| Contact | Keith Kretchmer |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2018-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858846007253 | K182207 | 000 |