510(k) K142679 ยท CBK Ventilator, Continuous, Facility Use
CARESCAPE R860
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Jun 12, 2015 |
| Received | Sep 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142679
| 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 |
| Aug 24, 2020 | GE Healthcare, LLC CARESCAPE R860 Ventilator
The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway press Terminated |
CBK | None listed |
| Nov 30, 2018 | GE Healthcare, LLC GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers:
a) 2066713-001 (single pack)
b) 2083208-001 (box of ten singles)
The CARESCAPE R860 ventilator is designed to provide mechanical Terminated |
CBK | None listed |
| Jun 28, 2018 | Datex-Ohmeda, Inc. The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010.
The CARESCAPE R860 ventilator is designe Terminated |
CBK | None listed |
| Jun 1, 2018 | Datex-Ohmeda, Inc. CARESCAPE R860 ventilators with software version 10SP05
Product Usage:
The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patient Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.