K921993 is an FDA 510(k) clearance for the ELS AUTOMATIC TUBING CLAMP SYSTEM, a Clamp, Tubing, Blood, Automatic (Class II — Special Controls, product code FIG), submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 5, 1994, 617 days after receiving the submission on April 28, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K921993 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 28, 1992 |
| Decision Date | January 05, 1994 |
| Days to Decision | 617 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIG — Clamp, Tubing, Blood, Automatic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |