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 |