The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extrasensr Ultrafiltration Monitor.
Device ID | K831433 |
510k Number | K831433 |
Device Name: | EXTRASENSR ULTRAFILTRATION MONITOR |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-04 |
Decision Date | 1983-06-02 |