The following data is part of a premarket notification filed by Audina Hearing Instrument with the FDA for Model Audina Ite Heating Aid.
| Device ID | K897024 |
| 510k Number | K897024 |
| Device Name: | MODEL AUDINA ITE HEATING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | AUDINA HEARING INSTRUMENT 150 WILDMERE ST. Longwood, FL 32750 |
| Contact | Frank J Robilotta |
| Correspondent | Frank J Robilotta AUDINA HEARING INSTRUMENT 150 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 | 1989-12-19 |
| Decision Date | 1990-04-18 |