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 |