The following data is part of a premarket notification filed by Brown Hearing Aid Centers with the FDA for Ite Type Hearing Aid H.a.f. Model Elite.
| Device ID | K881754 |
| 510k Number | K881754 |
| Device Name: | ITE TYPE HEARING AID H.A.F. MODEL ELITE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | BROWN HEARING AID CENTERS P.O. BOX 61 407 N. 9TH STREET Orange, TX 77630 |
| Contact | Leroy Brown |
| Correspondent | Leroy Brown BROWN HEARING AID CENTERS P.O. BOX 61 407 N. 9TH STREET Orange, TX 77630 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-25 |
| Decision Date | 1988-07-25 |