The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Blood Monitor Bmm 10-4.
| Device ID | K831404 |
| 510k Number | K831404 |
| Device Name: | BLOOD MONITOR BMM 10-4 |
| Classification | System, Blood, Extracorporeal And Accessories |
| Applicant | GAMBRO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LLB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-02 |
| Decision Date | 1984-04-25 |