K013843 is an FDA 510(k) clearance for the AUTOSET SPIRIT CPAP SYSTEM. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by ResMed Corp (Poway, US). The FDA issued a Cleared decision on July 16, 2002, 238 days after receiving the submission on November 20, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K013843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2001 |
| Decision Date | July 16, 2002 |
| Days to Decision | 238 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 |