The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Dialysis Machines Dm-346 & 346-1.
| Device ID | K772163 |
| 510k Number | K772163 |
| Device Name: | DIALYSIS MACHINES DM-346 & 346-1 |
| Classification | System, Dialysate Delivery, Recirculating, Single Pass |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIJ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-16 |
| Decision Date | 1977-11-28 |