K091343 is an FDA 510(k) clearance for the MRI NEURO DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Surgivision, Inc. (Houston, US). The FDA issued a Cleared decision on September 22, 2009, 139 days after receiving the submission on May 6, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K091343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2009 |
| Decision Date | September 22, 2009 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |