K983714 is an FDA 510(k) clearance for the SOLARTEC SOURCE 270, MODEL # 90123, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Cogent Light Technologies, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on December 23, 1998, 63 days after receiving the submission on October 21, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K983714 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 1998 |
| Decision Date | December 23, 1998 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFS — Image, Illumination, Fiberoptic, For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |