The following data is part of a premarket notification filed by Circadiance Llc with the FDA for Sleepweaver Elan Nasal Cpap Mask.
| Device ID | K120757 |
| 510k Number | K120757 |
| Device Name: | SLEEPWEAVER ELAN NASAL CPAP MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CIRCADIANCE LLC 1060 Corporate Lane Export, PA 15632 |
| Contact | David Groll |
| Correspondent | David Groll CIRCADIANCE LLC 1060 Corporate Lane Export, PA 15632 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-13 |
| Decision Date | 2012-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B036100782 | K120757 | 000 |
| B036100656 | K120757 | 000 |
| B036100655 | K120757 | 000 |
| B036100654 | K120757 | 000 |
| B036100653 | K120757 | 000 |
| B036100563 | K120757 | 000 |
| B036100522 | K120757 | 000 |
| B036100521 | K120757 | 000 |
| B036100520 | K120757 | 000 |
| B036100519 | K120757 | 000 |
| B036100518 | K120757 | 000 |
| B036100485 | K120757 | 000 |
| B036100484 | K120757 | 000 |
| B036100483 | K120757 | 000 |
| B036100482 | K120757 | 000 |
| B036100657 | K120757 | 000 |
| B036100663 | K120757 | 000 |
| B036100746 | K120757 | 000 |
| B036100745 | K120757 | 000 |
| B036100744 | K120757 | 000 |
| B036100743 | K120757 | 000 |
| B036100742 | K120757 | 000 |
| B036100731 | K120757 | 000 |
| B036100730 | K120757 | 000 |
| B036100729 | K120757 | 000 |
| B036100728 | K120757 | 000 |
| B036100727 | K120757 | 000 |
| B036100667 | K120757 | 000 |
| B036100666 | K120757 | 000 |
| B036100665 | K120757 | 000 |
| B036100664 | K120757 | 000 |
| B036100481 | K120757 | 000 |