K900770 is an FDA 510(k) clearance for the HOME URODATA SYSTEM(TM). This device is classified as a Uroflowmeter (Class II - Special Controls, product code EXY).
Submitted by Biodan Medical Systems, Ltd. (Israel, IL). The FDA issued a Cleared decision on June 8, 1990, 112 days after receiving the submission on February 16, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.
| 510(k) Number | K900770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1990 |
| Decision Date | June 08, 1990 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXY — Uroflowmeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1800 |