The following data is part of a premarket notification filed by Siegen Corp. with the FDA for Siegen Headphones.
| Device ID | K862430 |
| 510k Number | K862430 |
| Device Name: | SIEGEN HEADPHONES |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | SIEGEN CORP. 2400 BAYSHORE FRONTAGE RD. Mountain View, CA 94043 |
| Contact | Bert Myers |
| Correspondent | Bert Myers SIEGEN CORP. 2400 BAYSHORE FRONTAGE RD. Mountain View, CA 94043 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-09-26 |