The following data is part of a premarket notification filed by Ear Tech, Inc. with the FDA for Ite Hearing Aid, Eartech/custom Aid Model Ca.
| Device ID | K882471 |
| 510k Number | K882471 |
| Device Name: | ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA |
| Classification | Hearing Aid, Air Conduction |
| Applicant | EAR TECH, INC. 303 US BLVD 301 W #643 Bradenton, FL 34205 |
| Contact | Mark A Krywko |
| Correspondent | Mark A Krywko EAR TECH, INC. 303 US BLVD 301 W #643 Bradenton, FL 34205 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-15 |
| Decision Date | 1988-08-26 |