510(k) K111116 ยท CBK Ventilator, Continuous, Facility Use
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
| Applicant | Datex-Ohmeda, Madison WI, US |
| Decision | Substantially Equivalent, Sep 9, 2011 |
| Received | Apr 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2022 | GE Healthcare, LLC Back up batteries in Ventilators labeled as the following:
a. CARESCAPE R860 Ventilators (K142679)
b. ENGSTROM (K111116)
c. ENGSTROM Carestation (K111116)
d. ENGSTROM PRO (K111116) Open, Classified |
CBK | None listed |
| Jun 6, 2022 | GE Healthcare, LLC Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators. Open, Classified |
CBK | None listed |
| Mar 24, 2015 | GE Healthcare GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators. Terminated |
CBK | None listed |
| Oct 15, 2013 | GE Healthcare, LLC GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom.
Intended for volume or pressure control ventilation. Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.