510(k) K162738 ยท CBK Ventilator, Continuous, Facility Use
Puritan Bennett 980 Ventilator System
| Applicant | Covidien, Boulder CO, US |
| Decision | Substantially Equivalent, Oct 27, 2017 |
| Received | Sep 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2020 | Covidien Llc Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation
SKU:
980 Open, Classified |
CBK | None listed |
| Dec 18, 2018 | COVIDIEN LLC Puritan Bennett 980 (PB980) ventilator series:
Puritan Bennett" 980 Pediatric Adult Ventilator
Puritan Bennett" 980 Neonatal Ventilator
Puritan Bennett" 980 Universal Ventilator
Product Usage:
The Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.