Submission Details
| 510(k) Number | K951596 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1995 |
| Decision Date | May 24, 1995 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
EARCLEAR
May 1995
Decision
47d
Days
—
Risk
About This 510(k) Submission
K951596 is an FDA 510(k) clearance for the EARCLEAR, a Device, Inflation, Middle Ear, submitted by Arisil Medical (Brooklyn, US). The FDA issued a Cleared decision on May 24, 1995, 47 days after receiving the submission on April 7, 1995. This device falls under the Ear, Nose, Throat review panel.
Device Classification
| Product Code | MJV — Device, Inflation, Middle Ear |
| Device Class | — |
Manufacturer
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