The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Console, Mobile For 3 Pumps W/masts.
| Device ID | K770002 |
| 510k Number | K770002 |
| Device Name: | CONSOLE, MOBILE FOR 3 PUMPS W/MASTS |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-01-03 |
| Decision Date | 1977-03-07 |