The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Easynet Body Position Module.
| Device ID | K040932 |
| 510k Number | K040932 |
| Device Name: | EASYNET BODY POSITION MODULE |
| Classification | Device, Sleep Assessment |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Chris Bolkan |
| Correspondent | Chris Bolkan CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-09 |
| Decision Date | 2004-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067100486 | K040932 | 000 |