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 |