The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Patient Monitoring Products.
| Device ID | K921343 |
| 510k Number | K921343 |
| Device Name: | COBE PATIENT MONITORING PRODUCTS |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1993-01-05 |