The following data is part of a premarket notification filed by Halifax Biomedical, Inc. with the FDA for Halifax Imaging Kit.
| Device ID | K182880 |
| 510k Number | K182880 |
| Device Name: | Halifax Imaging Kit |
| Classification | System, X-ray, Stationary |
| Applicant | Halifax Biomedical, Inc. 11493 Route 19 Mabou, CA B0e1x0 |
| Contact | Crystal Jones |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | KPR |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2018-10-31 |
| Summary: | summary |