The following data is part of a premarket notification filed by Arisil Medical with the FDA for Earclear.
| Device ID | K951596 |
| 510k Number | K951596 |
| Device Name: | EARCLEAR |
| Classification | Device, Inflation, Middle Ear |
| Applicant | ARISIL MEDICAL 450 CLINTON ST. Brooklyn, NY 11231 |
| Contact | Daniel S Arick |
| Correspondent | Daniel S Arick ARISIL MEDICAL 450 CLINTON ST. Brooklyn, NY 11231 |
| Product Code | MJV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-05-24 |