K920574 is an FDA 510(k) clearance for the CAMSYS 6300. This device is classified as a Cystometer, Electrical Recording (Class II - Special Controls, product code EXQ).
Submitted by F.M. Wiest USA, Inc. (Oradell, US). The FDA issued a Cleared decision on February 17, 1993, 376 days after receiving the submission on February 7, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K920574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1992 |
| Decision Date | February 17, 1993 |
| Days to Decision | 376 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXQ — Cystometer, Electrical Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |