K924440 is an FDA 510(k) clearance for the U.S. MEDICAL PS-7000 DIALYSIS SCALE. This device is classified as a Dilator, Urethral (Class II - Special Controls, product code KOE).
Submitted by U.S. Medical Corp. (Higgaum, US). The FDA issued a Cleared decision on May 26, 1993, 267 days after receiving the submission on September 1, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K924440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1992 |
| Decision Date | May 26, 1993 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOE — Dilator, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5520 |