The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Autotransfusion Blood Collection Reservoir.
| Device ID | K915737 |
| 510k Number | K915737 |
| Device Name: | AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Contact | Harold W Bryan |
| Correspondent | Harold W Bryan ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-09-03 |