K954798 is an FDA 510(k) clearance for the 7100 SWALLOWING WORKSTATION, a Monitor, Esophageal Motility, Anorectal Motility, And Tube (Class II — Special Controls, product code KLA), submitted by Kay Elemetrics Corp. (Lincoln Park, US). The FDA issued a Cleared decision on June 4, 1996, 230 days after receiving the submission on October 18, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K954798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 1995 |
| Decision Date | June 04, 1996 |
| Days to Decision | 230 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 |