K200480 is an FDA 510(k) clearance for the DreamStation 2 System, DreamStation 2 Advanced System. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 10, 2020, 134 days after receiving the submission on February 27, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K200480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2020 |
| Decision Date | July 10, 2020 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |