The following data is part of a premarket notification filed by Ear-tronics, Inc. with the FDA for Ite Hearing Aid, Ear-tronics Models: M1-m23.
| Device ID | K881299 |
| 510k Number | K881299 |
| Device Name: | ITE HEARING AID, EAR-TRONICS MODELS: M1-M23 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | EAR-TRONICS, INC. 1403 CAPE CORAL PKWY. Cape Coral, FL 33904 |
| Contact | Robert L Hooper |
| Correspondent | Robert L Hooper EAR-TRONICS, INC. 1403 CAPE CORAL PKWY. Cape Coral, FL 33904 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-08-05 |