The following data is part of a premarket notification filed by Devilbiss Healthcare Llc with the FDA for Devilbiss Intellipap / Sleepcube Auto Bilevel.
| Device ID | K112220 |
| 510k Number | K112220 |
| Device Name: | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | DEVILBISS HEALTHCARE LLC 100 DEVILBISS HEALTHCARE Somerset, PA 15501 |
| Contact | James P Froehlich |
| Correspondent | James P Froehlich DEVILBISS HEALTHCARE LLC 100 DEVILBISS HEALTHCARE Somerset, PA 15501 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-02 |
| Decision Date | 2011-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085304008798 | K112220 | 000 |
| 00885304000198 | K112220 | 000 |
| 00885304000181 | K112220 | 000 |
| 00885304000174 | K112220 | 000 |
| 00885304000167 | K112220 | 000 |
| 00885304000150 | K112220 | 000 |
| 00885304007449 | K112220 | 000 |
| 00885304008798 | K112220 | 000 |
| 00885304000280 | K112220 | 000 |
| 10885304001055 | K112220 | 000 |
| 00885304000204 | K112220 | 000 |
| 00885304000228 | K112220 | 000 |
| 10885304022159 | K112220 | 000 |
| 10885304022104 | K112220 | 000 |
| 00885304009535 | K112220 | 000 |
| 00885304008941 | K112220 | 000 |
| 00885304008293 | K112220 | 000 |
| 00885304001065 | K112220 | 000 |
| 00885304001058 | K112220 | 000 |
| 00885304000358 | K112220 | 000 |
| 00885304000341 | K112220 | 000 |
| 00853040087988 | K112220 | 000 |