K936198 is an FDA 510(k) clearance for the ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on April 6, 1994, 98 days after receiving the submission on December 29, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K936198 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 1993 |
| Decision Date | April 06, 1994 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | GCT — Light Source, Endoscope, Xenon Arc |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |