K930581 is an FDA 510(k) clearance for the E-Z-FLATE, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on July 1, 1994, 512 days after receiving the submission on February 4, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K930581 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 1993 |
| Decision Date | July 01, 1994 |
| Days to Decision | 512 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCX — Insufflator, Automatic Carbon-dioxide For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |