510(k) K112729 ยท CBK Ventilator, Continuous, Facility Use
BLEASE700/900 SERIES VENTILATORS
| Applicant | Spacelabs Healthcare, Nederland CO, US |
| Decision | Substantially Equivalent, Jun 11, 2012 |
| Received | Sep 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2015 | Del Mar Reynolds Medical, Ltd. Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators.
Designed specifically for the mechanical ventilation of adult and pediat Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.