The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Easynet Oximeter Module.
| Device ID | K061706 |
| 510k Number | K061706 |
| Device Name: | CADWELL EASYNET OXIMETER MODULE |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-16 |
| Decision Date | 2007-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067100615 | K061706 | 000 |
| 00840067100493 | K061706 | 000 |
| 00840067103951 | K061706 | 000 |