The following data is part of a premarket notification filed by Imtmedical Ag with the FDA for Bellavista 1000.
| Device ID | K163127 |
| 510k Number | K163127 |
| Device Name: | Bellavista 1000 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | IMTMEDICAL AG GEWERBESTRASSE 8 Buchs Sg, CH Ch-9470 |
| Contact | Beat Keller |
| Correspondent | Paul Dryden PROMEDIC, LLC 24301 WOODSAGE DR. Bonita Springs, FL 34134 -2958 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-07-31 |
| Summary: | summary |