K941543 is an FDA 510(k) clearance for the DIAL MEDICAL KIT, a Accessories, Blood Circuit, Hemodialysis (Class II — Special Controls, product code KOC), submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on February 16, 1995, 323 days after receiving the submission on March 30, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K941543 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | March 30, 1994 |
| Decision Date | February 16, 1995 |
| Days to Decision | 323 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 |