The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Acr 2500 Cardiotomy Reservoir Filter.
| Device ID | K842391 |
| 510k Number | K842391 |
| Device Name: | ACR 2500 CARDIOTOMY RESERVOIR FILTER |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-18 |
| Decision Date | 1985-05-21 |