K083598 is an FDA 510(k) clearance for the KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION. This device is classified as a Endoscopic Central Control Unit (Class II - Special Controls, product code ODA).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on May 29, 2009, 175 days after receiving the submission on December 5, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command..
| 510(k) Number | K083598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2008 |
| Decision Date | May 29, 2009 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODA — Endoscopic Central Control Unit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command. |