The following data is part of a premarket notification filed by Frye Electronics, Inc. with the FDA for Hearlab Aca.
| Device ID | K123701 |
| 510k Number | K123701 |
| Device Name: | HEARLAB ACA |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | FRYE ELECTRONICS, INC. 9826 S.W. TIGARD ST. Tigard, OR 97223 |
| Contact | Kristina Frye |
| Correspondent | Kristina Frye FRYE ELECTRONICS, INC. 9826 S.W. TIGARD ST. Tigard, OR 97223 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2013-04-05 |