The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Saturation Cell.
| Device ID | K843709 |
| 510k Number | K843709 |
| Device Name: | COBE SATURATION CELL |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Holland Hickey |
| Correspondent | Holland Hickey COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-21 |
| Decision Date | 1984-10-24 |