The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Air Emboli Protection System (aeps).
| Device ID | K900910 |
| 510k Number | K900910 |
| Device Name: | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-05-22 |