K963330 is an FDA 510(k) clearance for the URODYNAMIC ANALYSIS MODULE, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Synectics Medical, Inc. (S-116 28 Stockholm, SE). The FDA issued a Cleared decision on April 3, 1997, 223 days after receiving the submission on August 23, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K963330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 23, 1996 |
| Decision Date | April 03, 1997 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1620 |