The following data is part of a premarket notification filed by Resmed Germany Inc. with the FDA for Stellar 150.
| Device ID | K103167 |
| 510k Number | K103167 |
| Device Name: | STELLAR 150 |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | RESMED GERMANY INC. FRAUNHOFERSTRASSE 16 Munchen, DE D-82152 |
| Contact | Sandra Grunwald |
| Correspondent | Sandra Grunwald RESMED GERMANY INC. FRAUNHOFERSTRASSE 16 Munchen, DE D-82152 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-27 |
| Decision Date | 2011-03-01 |
| Summary: | summary |