The following data is part of a premarket notification filed by Class A Ent. with the FDA for Eeg Electrodes Model 445 Series.
| Device ID | K982053 |
| 510k Number | K982053 |
| Device Name: | EEG ELECTRODES MODEL 445 SERIES |
| Classification | Electrode, Cutaneous |
| Applicant | CLASS A ENT. 7607 LUCERNE VISTA Yucca Valley, CA 92284 |
| Contact | Janice A Audi |
| Correspondent | Janice A Audi CLASS A ENT. 7607 LUCERNE VISTA Yucca Valley, CA 92284 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-11 |
| Decision Date | 1999-04-20 |