The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Negative Press. Arterial Blood.
Device ID | K842436 |
510k Number | K842436 |
Device Name: | ERIKA NEGATIVE PRESS. ARTERIAL BLOOD |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | ERIKA, 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 | 1984-06-20 |
Decision Date | 1984-07-13 |