The following data is part of a premarket notification filed by Circadiance, Llc with the FDA for Sleepweaver 3d Nasal Mask.
| Device ID | K162905 |
| 510k Number | K162905 |
| Device Name: | SleepWeaver 3D Nasal Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Circadiance, LLC 1300 RODI RD Turtle Creek, PA 15145 |
| Contact | James Gianoutsos |
| Correspondent | James Gianoutsos Circadiance, LLC 1300 RODI RD Turtle Creek, PA 15145 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B036101517 | K162905 | 000 |
| B036101516 | K162905 | 000 |
| B036101496 | K162905 | 000 |
| B036101544 | K162905 | 000 |
| B036101539 | K162905 | 000 |