The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Ite 8000, 7000, 6000 Ite Hearing Aid.
| Device ID | K900675 |
| 510k Number | K900675 |
| Device Name: | PHONAK ITE 8000, 7000, 6000 ITE HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville, IL 60566 |
| Contact | D Huddleston |
| Correspondent | D Huddleston PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville, IL 60566 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-12 |
| Decision Date | 1990-05-23 |