K061622 is an FDA 510(k) clearance for the PS SERIES, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Photonic Optische Gerate Gesmbh & Cokg (Vienna, AT). The FDA issued a Cleared decision on March 5, 2007, 266 days after receiving the submission on June 12, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K061622 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2006 |
| Decision Date | March 05, 2007 |
| Days to Decision | 266 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 |