ApneaTrak
Standard Polysomnograph With Electroencephalograph
Cadwell Industries, Inc.
The following data is part of a premarket notification filed by Cadwell Industries, Inc. with the FDA for Apneatrak.
Pre-market Notification Details
| Device ID | K192624 |
| 510k Number | K192624 |
| Device Name: | ApneaTrak |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick, WA 99336 |
| Contact | James Blevins |
| Correspondent | James Blevins Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick, WA 99336 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2020-02-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067102503 | K192624 | 000 |
Trademark Results [ApneaTrak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APNEATRAK 87589907 5932552 Live/Registered |
Cadwell Industries, Inc. 2017-08-30 |
 APNEATRAK 85164016 4021821 Dead/Cancelled |
Cadwell Industries, Inc. 2010-10-28 |
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