The following data is part of a premarket notification filed by Action Labs, Inc. with the FDA for Hearing Aid (all-in-the-ear).
| Device ID | K930542 |
| 510k Number | K930542 |
| Device Name: | HEARING AID (ALL-IN-THE-EAR) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ACTION LABS, INC. P.O. BOX 2195 Independence, MO 64055 |
| Contact | Ron Toles |
| Correspondent | Ron Toles ACTION LABS, INC. P.O. BOX 2195 Independence, MO 64055 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-02 |
| Decision Date | 1993-04-07 |