The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for 40-hz Auditory Evoked Response Test.
| Device ID | K862361 |
| 510k Number | K862361 |
| Device Name: | 40-HZ AUDITORY EVOKED RESPONSE TEST |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Cadwell, Dds |
| Correspondent | Cadwell, Dds CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-23 |
| Decision Date | 1986-09-17 |