K914793 is an FDA 510(k) clearance for the MONOCRYSTANT PH/LES CATHETER, MODIFICATION, a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II — Special Controls, product code KLA), submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on December 13, 1993, 840 days after receiving the submission on August 26, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K914793 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 1991 |
| Decision Date | December 13, 1993 |
| Days to Decision | 840 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KLA — Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1725 |