K091178 is an FDA 510(k) clearance for the MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN. This device is classified as a Cover, Barrier, Protective (Class II - Special Controls, product code MMP).
Submitted by Mtp Medical Technical Promotion GmbH (El Segundo, US). The FDA issued a Cleared decision on July 31, 2009, 100 days after receiving the submission on April 22, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K091178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2009 |
| Decision Date | July 31, 2009 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MMP — Cover, Barrier, Protective |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |