K944673 is an FDA 510(k) clearance for the MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on April 10, 1996, 566 days after receiving the submission on September 22, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K944673 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 1994 |
| Decision Date | April 10, 1996 |
| Days to Decision | 566 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |