K953999 is an FDA 510(k) clearance for the DANTEC DA CAPO. This device is classified as a Uroflowmeter (Class II - Special Controls, product code EXY).
Submitted by Dantec Medical, Inc. (Allendale, US). The FDA issued a Cleared decision on November 21, 1995, 89 days after receiving the submission on August 24, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K953999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1995 |
| Decision Date | November 21, 1995 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXY — Uroflowmeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1800 |