The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Intellipap/sleepcube Bilevel S/st.
| Device ID | K091919 |
| 510k Number | K091919 |
| Device Name: | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Betty L Miller |
| Correspondent | Betty L Miller SUNRISE MEDICAL 100 DEVILBISS DR. 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 | 2009-06-30 |
| Decision Date | 2009-09-28 |
| Summary: | summary |