K880391 is an FDA 510(k) clearance for the DACOMED CYSTOMETER. This device is classified as a Cystometer, Electrical Recording (Class II - Special Controls, product code EXQ).
Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on April 27, 1988, 89 days after receiving the submission on January 29, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K880391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1988 |
| Decision Date | April 27, 1988 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXQ — Cystometer, Electrical Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |