The following data is part of a premarket notification filed by Circadiance Llc with the FDA for Sleepweaver Anew Full Face Soft Cloth Pap Mask.
| Device ID | K130481 |
| 510k Number | K130481 |
| Device Name: | SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CIRCADIANCE LLC 3919 WILLIAM PENN HWY. SUITE 200 Murrysville, PA 15668 |
| Contact | Ryan T Kasun |
| Correspondent | Ryan T Kasun CIRCADIANCE LLC 3919 WILLIAM PENN HWY. SUITE 200 Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B036100980 | K130481 | 000 |
| B036100975 | K130481 | 000 |
| B036100970 | K130481 | 000 |
| B036100965 | K130481 | 000 |
| B036100964 | K130481 | 000 |
| B036100960 | K130481 | 000 |
| B036100954 | K130481 | 000 |