The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Cobe Hemodynamic Recirculation Monitor.
| Device ID | K954003 |
| 510k Number | K954003 |
| Device Name: | COBE HEMODYNAMIC RECIRCULATION MONITOR |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | COBE RENAL CARE, INC. 1201 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull COBE RENAL CARE, INC. 1201 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-25 |
| Decision Date | 1997-02-06 |