K912354 is an FDA 510(k) clearance for the OLYMOUS XLS XENON LIGHT SOURCE. This device is classified as a Light Source, Endoscope, Xenon Arc (Class II - Special Controls, product code GCT).
Submitted by Perkinelmer Optoelectronics (Suunyvale, US). The FDA issued a Cleared decision on August 16, 1991, 80 days after receiving the submission on May 28, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K912354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1991 |
| Decision Date | August 16, 1991 |
| Days to Decision | 80 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 |