The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Easy Ambulatory Eeg.
| Device ID | K946094 |
| 510k Number | K946094 |
| Device Name: | CADWELL EASY AMBULATORY EEG |
| Classification | Full-montage Standard Electroencephalograph |
| 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-14 |
| Decision Date | 1995-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067100660 | K946094 | 000 |
| 00840067100592 | K946094 | 000 |
| 00840067100455 | K946094 | 000 |