K925581 is an FDA 510(k) clearance for the BAXTER BIOSTAT 1000 UREA MONITOR. This device is classified as a System Accessories, Extracorporeal (Class II - Special Controls, product code KXM).
Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on May 3, 1995, 909 days after receiving the submission on November 5, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K925581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1992 |
| Decision Date | May 03, 1995 |
| Days to Decision | 909 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KXM — System Accessories, Extracorporeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |