K922821 is an FDA 510(k) clearance for the YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Yellow Springs Instrument Co., Inc. (Yellow Springs, US). The FDA issued a Cleared decision on November 23, 1992, 165 days after receiving the submission on June 11, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K922821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1992 |
| Decision Date | November 23, 1992 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |