K101850 is an FDA 510(k) clearance for the SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on March 2, 2011, 244 days after receiving the submission on July 1, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K101850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2010 |
| Decision Date | March 02, 2011 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK - Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |