The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Mbm(tm) Monitral (r) Bicarbonate Module.
| Device ID | K850179 |
| 510k Number | K850179 |
| Device Name: | MBM(TM) MONITRAL (R) BICARBONATE MODULE |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Contact | Jean-louis Fressinet |
| Correspondent | Jean-louis Fressinet HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-17 |
| Decision Date | 1985-02-28 |