The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Blood Safety Module Bsm2.
| Device ID | K833440 |
| 510k Number | K833440 |
| Device Name: | BLOOD SAFETY MODULE BSM2 |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-05 |
| Decision Date | 1983-12-08 |