K052573 is an FDA 510(k) clearance for the STARDUST II. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 13, 2005, 85 days after receiving the submission on September 19, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K052573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2005 |
| Decision Date | December 13, 2005 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNR — Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |