K010692 is an FDA 510(k) clearance for the THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Spintech, Inc. (Washington, US). The FDA issued a Cleared decision on June 29, 2001, 113 days after receiving the submission on March 8, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K010692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2001 |
| Decision Date | June 29, 2001 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |