The following data is part of a premarket notification filed by Circadiance Llc with the FDA for Sleepweaver Nasal Cpap Mask.
| Device ID | K092362 |
| 510k Number | K092362 |
| Device Name: | SLEEPWEAVER NASAL CPAP MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CIRCADIANCE LLC 3554 NORTH HILLS RD. Murrysville, PA 15668 |
| Contact | David Groll |
| Correspondent | David Groll CIRCADIANCE LLC 3554 NORTH HILLS RD. 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 | 2009-08-04 |
| Decision Date | 2009-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B036101233 | K092362 | 000 |
| B036100332 | K092362 | 000 |
| B036100295 | K092362 | 000 |
| B036100293 | K092362 | 000 |
| B036100291 | K092362 | 000 |
| B036100289 | K092362 | 000 |
| B036100285 | K092362 | 000 |
| B036100281 | K092362 | 000 |
| B036100277 | K092362 | 000 |
| B036100336 | K092362 | 000 |
| B036101224 | K092362 | 000 |
| B036101232 | K092362 | 000 |
| B036101231 | K092362 | 000 |
| B036101230 | K092362 | 000 |
| B036101229 | K092362 | 000 |
| B036101228 | K092362 | 000 |
| B036101227 | K092362 | 000 |
| B036101226 | K092362 | 000 |
| B036101225 | K092362 | 000 |
| B036100274 | K092362 | 000 |