The following data is part of a premarket notification filed by Halifax Biomedical, Inc. with the FDA for Sr Suite 1.0.
| Device ID | K121345 |
| 510k Number | K121345 |
| Device Name: | SR SUITE 1.0 |
| Classification | System, X-ray, Stationary |
| Applicant | HALIFAX BIOMEDICAL, INC. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm HALIFAX BIOMEDICAL, INC. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-04 |
| Decision Date | 2012-06-01 |
| Summary: | summary |