Submission Details
| 510(k) Number | K962483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 1996 |
| Decision Date | November 19, 1996 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
K962483 is an FDA 510(k) clearance for the MIDAS REX III MOTOR, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 19, 1996, 146 days after receiving the submission on June 26, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K962483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 1996 |
| Decision Date | November 19, 1996 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4370 |