The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Negative Pressure Arterial Blood Line.
Device ID | K822796 |
510k Number | K822796 |
Device Name: | NEGATIVE PRESSURE ARTERIAL BLOOD LINE |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | ERIKA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-16 |
Decision Date | 1982-10-18 |