The following data is part of a premarket notification filed by Siegen Corp. with the FDA for Siegen Surface Electrodes.
| Device ID | K844646 |
| 510k Number | K844646 |
| Device Name: | SIEGEN SURFACE ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | SIEGEN CORP. 2400 BAYSHORE FRONTAGE RD. Mountain View, CA 94043 |
| Contact | Capers W Mcdonald |
| Correspondent | Capers W Mcdonald SIEGEN CORP. 2400 BAYSHORE FRONTAGE RD. Mountain View, CA 94043 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-29 |
| Decision Date | 1984-12-11 |