The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Ambulatory Eeg Playback.
| Device ID | K872183 |
| 510k Number | K872183 |
| Device Name: | AMBULATORY EEG PLAYBACK |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton Cadwell |
| Correspondent | Carlton 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 | 1987-06-08 |
| Decision Date | 1987-07-21 |