The following data is part of a premarket notification filed by Resmed Corp with the FDA for Galapogos.
| Device ID | K200565 |
| 510k Number | K200565 |
| Device Name: | Galapogos |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ResMed Corp 9001 Spectrum Center Blvd San Diego, CA 92123 |
| Contact | Rose Malonzo |
| Correspondent | Rose Malonzo ResMed Corp 9001 Spectrum Center Blvd San Diego, CA 92123 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-04 |
| Decision Date | 2021-01-17 |