K073401 is an FDA 510(k) clearance for the EARPOPPER, MODEL EP-2000, EP-2100, EP-3000. This device is classified as a Device, Inflation, Middle Ear.
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 14, 2008, 101 days after receiving the submission on December 4, 2007.
This device falls under the Ear, Nose, Throat FDA review panel.
| 510(k) Number | K073401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2007 |
| Decision Date | March 14, 2008 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MJV — Device, Inflation, Middle Ear |
| Device Class | — |