The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Negat. Pressure Arter. Blood Line.
| Device ID | K822225 |
| 510k Number | K822225 |
| Device Name: | ERIKA NEGAT. PRESSURE ARTER. 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 | 1982-07-27 |
| Decision Date | 1982-08-16 |