The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Bicarbonate/variable Sodium Kit-dm-367.
| Device ID | K830908 |
| 510k Number | K830908 |
| Device Name: | BICARBONATE/VARIABLE SODIUM KIT-DM-367 |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-06-08 |