The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for New Cobe Saturation/hematocrit Monitor.
| Device ID | K904336 |
| 510k Number | K904336 |
| Device Name: | NEW COBE SATURATION/HEMATOCRIT MONITOR |
| Classification | Instrument, Hematocrit, Automated |
| Applicant | COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada, CO 80004 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada, CO 80004 |
| Product Code | GKF |
| CFR Regulation Number | 864.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1990-12-27 |