The following data is part of a premarket notification filed by Circadiance, Llc with the FDA for Sleepweaver Advance Pediatric Nasal Cpap Mask.
| Device ID | K151683 |
| 510k Number | K151683 |
| Device Name: | SleepWeaver Advance Pediatric Nasal CPAP Mask |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Circadiance, LLC 1060 Corporate Lane Export, PA 15632 |
| Contact | David Groll |
| Correspondent | Pooja Roychoudhury Regulatory & Quality Solutions, LLC 2790 Mosside Blvd, Suite 800 Monroeville, PA 15146 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-22 |
| Decision Date | 2016-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B036101328 | K151683 | 000 |
| B036101320 | K151683 | 000 |
| B036101321 | K151683 | 000 |
| B036101322 | K151683 | 000 |
| B036101323 | K151683 | 000 |
| B036101324 | K151683 | 000 |
| B036101325 | K151683 | 000 |
| B036101326 | K151683 | 000 |
| B036101327 | K151683 | 000 |
| B036101319 | K151683 | 000 |