The following data is part of a premarket notification filed by Audina Hearing Instrument with the FDA for Audina 153 Behind The Ear And Audina 158 Behind The Ear.
| Device ID | K964816 |
| 510k Number | K964816 |
| Device Name: | AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR |
| Classification | Hearing Aid, Air Conduction |
| Applicant | AUDINA HEARING INSTRUMENT 150 EAST WILDMERE ST. Longwood, FL 32750 |
| Contact | Frank J Robilotta |
| Correspondent | Frank J Robilotta AUDINA HEARING INSTRUMENT 150 EAST WILDMERE ST. Longwood, FL 32750 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-01-17 |