K912374 is an FDA 510(k) clearance for the BARD(R) UROTACK(R) 210 MONITORING SYSTEM. This device is classified as a Accessories, Blood Circuit, Hemodialysis (Class II - Special Controls, product code KOC).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on March 31, 1992, 307 days after receiving the submission on May 29, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K912374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1991 |
| Decision Date | March 31, 1992 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOC — Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |