The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Accessory Interface Module (aim).
| Device ID | K861860 |
| 510k Number | K861860 |
| Device Name: | COBE ACCESSORY INTERFACE MODULE (AIM) |
| Classification | Detector, Bubble, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | KRL |
| CFR Regulation Number | 870.4205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-14 |
| Decision Date | 1986-07-18 |