The following data is part of a premarket notification filed by Resmed Germany Inc. with the FDA for Stellar 150.
| Device ID | K113640 |
| 510k Number | K113640 |
| Device Name: | STELLAR 150 |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | RESMED GERMANY INC. 9001 SPECTRUMA CENTER BOULEVARD San Diego, CA 92123 |
| Contact | David D'cruz |
| Correspondent | David D'cruz RESMED GERMANY INC. 9001 SPECTRUMA CENTER BOULEVARD San Diego, CA 92123 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-09 |
| Decision Date | 2012-04-05 |
| Summary: | summary |