The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extrasensr Ultrafiltration Monitor.
| Device ID | K811972 |
| 510k Number | K811972 |
| Device Name: | EXTRASENSR ULTRAFILTRATION MONITOR |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-10 |
| Decision Date | 1981-11-16 |