K083112 is an FDA 510(k) clearance for the PRIMADO. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Nakanishi, Inc. (Washington, US). The FDA issued a Cleared decision on April 29, 2009, 190 days after receiving the submission on October 21, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K083112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2008 |
| Decision Date | April 29, 2009 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBC — Motor, Drill, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4360 |