The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Emergency Power Source 43610-000.
| Device ID | K842138 |
| 510k Number | K842138 |
| Device Name: | COBE EMERGENCY POWER SOURCE 43610-000 |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-08-03 |