The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electromedics El-series Cardiotomy Reservoir.
| Device ID | K926250 |
| 510k Number | K926250 |
| Device Name: | ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Contact | Harold W Bryan |
| Correspondent | Harold W Bryan ELECTROMEDICS, INC. 7337 SOUTH REVERE PKWY. Englewood, CO 80112 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-14 |
| Decision Date | 1993-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994842941 | K926250 | 000 |
| 20613994842934 | K926250 | 000 |
| 20613994842927 | K926250 | 000 |
| 20673978523594 | K926250 | 000 |
| 20673978523587 | K926250 | 000 |
| 20673978523570 | K926250 | 000 |
| 10673978522491 | K926250 | 000 |