The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Freedom Eeg Device.
Device ID | K894276 |
510k Number | K894276 |
Device Name: | CADWELL FREEDOM EEG DEVICE |
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 | 1989-06-23 |
Decision Date | 1989-09-29 |