The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Eeg Cup Electrode.
| Device ID | K933808 |
| 510k Number | K933808 |
| Device Name: | EEG CUP ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton M Cadwell |
| Correspondent | Carlton M Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-04 |
| Decision Date | 1994-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067102725 | K933808 | 000 |
| 00840067100004 | K933808 | 000 |
| 00840067101025 | K933808 | 000 |
| 00840067101087 | K933808 | 000 |
| 00840067101100 | K933808 | 000 |
| 00840067101612 | K933808 | 000 |
| 00840067101629 | K933808 | 000 |
| 00840067101636 | K933808 | 000 |
| 00840067101650 | K933808 | 000 |
| 00840067101667 | K933808 | 000 |
| 00840067101674 | K933808 | 000 |
| 00840067102015 | K933808 | 000 |
| 00840067102770 | K933808 | 000 |