K111622 is an FDA 510(k) clearance for the UNIMAX ANTI-FOG SOLUTION. This device is classified as a Anti Fog Solution And Accessories, Endoscopy (Class II - Special Controls, product code OCT).
Submitted by Unimax Medical Systems, Inc. (Taipei County, TW). The FDA issued a Cleared decision on September 9, 2011, 91 days after receiving the submission on June 10, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens..
| 510(k) Number | K111622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2011 |
| Decision Date | September 09, 2011 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCT - Anti Fog Solution And Accessories, Endoscopy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens. |