K080802 is an FDA 510(k) clearance for the EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on April 30, 2008, 40 days after receiving the submission on March 21, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K080802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2008 |
| Decision Date | April 30, 2008 |
| Days to Decision | 40 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBE — Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |