The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Intellipap/ Sleepcube Bilevel St, Dv56 St Series.
| Device ID | K093070 |
| 510k Number | K093070 |
| Device Name: | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Contact | Betty Lou Miller |
| Correspondent | Betty Lou Miller SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-01-26 |
| Summary: | summary |