The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Easynet Nasal Pressure Module.
| Device ID | K061705 |
| 510k Number | K061705 |
| Device Name: | CADWELL EASYNET NASAL PRESSURE MODULE |
| Classification | Ventilatory Effort Recorder |
| 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 | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-16 |
| Decision Date | 2006-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067100462 | K061705 | 000 |