510(k) K142149 ยท ECX Cylinder, Compressed Gas, And Valve
OXYTOTE INFINITY SERIES VIPR SYSTEMS
| Applicant | Western/Scott Fetzer Co., Westlake OH, US |
| Decision | Substantially Equivalent, Apr 17, 2015 |
| Received | Aug 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Western / Scott Fetzer Company Grab n Go Opti series VIPR system
Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When a Terminated |
ECX | None listed |
| Aug 15, 2019 | Western / Scott Fetzer Company Grab n Go Opti series VIPR system
Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When a Terminated |
ECX | None listed |
| Aug 15, 2019 | Western / Scott Fetzer Company Grab n Go Opti series VIPR system
Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When a Terminated |
ECX | None listed |
| Aug 15, 2019 | Western / Scott Fetzer Company Grab n Go Opti series VIPR system
Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When a Terminated |
ECX | None listed |
| Aug 15, 2019 | Western / Scott Fetzer Company Grab n Go Opti series VIPR system
Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When a Terminated |
ECX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.