The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Cadwell Flex Eeg/psg.
| Device ID | K133355 |
| 510k Number | K133355 |
| Device Name: | CADWELL FLEX EEG/PSG |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | CADWELL INDUSTRIES, INC. 909 N Kellogg St Kennewick, WA 99336 |
| Contact | John Cadwell Jr. |
| Correspondent | John Cadwell Jr. CADWELL INDUSTRIES, INC. 909 N Kellogg St Kennewick, WA 99336 |
| Product Code | GWQ |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWL |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OLV |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-31 |
| Decision Date | 2014-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067100585 | K133355 | 000 |
| 00840067100080 | K133355 | 000 |
| 00840067100073 | K133355 | 000 |
| 00840067100066 | K133355 | 000 |
| 00840067102824 | K133355 | 000 |
| 00840067102817 | K133355 | 000 |