K954003 is an FDA 510(k) clearance for the COBE HEMODYNAMIC RECIRCULATION MONITOR. This device is classified as a System, Hemodialysis, Access Recirculation Monitoring (Class II - Special Controls, product code MQS).
Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on February 6, 1997, 531 days after receiving the submission on August 25, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K954003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1995 |
| Decision Date | February 06, 1997 |
| Days to Decision | 531 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MQS — System, Hemodialysis, Access Recirculation Monitoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |