The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Saturation/hematocrit Monitor W/ Fiber Optic.
| Device ID | K902758 |
| 510k Number | K902758 |
| Device Name: | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-25 |
| Decision Date | 1990-08-23 |