Company ยท US
Western / Scott Fetzer Company
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2015. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Western/Scott Fetzer Company Digital VIPR
ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only)
ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder)
MNDR-600, Western Oxytote DTE Digital VIPR Open, Classified |
CAN | None listed |
| Oct 16, 2021 | Western/Scott Fetzer Company Western Oxytote DTE Digital VIPR System (with E-size cylinder)
Model: MNDS-603 Open, Classified |
CAN | None listed |
| Oct 16, 2021 | Western/Scott Fetzer Company Western Oxytote DTE Digital VIPR System (with D-size cylinder)
Model: MNDS-602 Open, Classified |
CAN | None listed |
| Oct 16, 2021 | Western/Scott Fetzer Company Western Oxytote DTE Digital VIPR (head only)
Model: MNDR-600 Open, Classified |
CAN | None listed |
| Oct 16, 2021 | Western/Scott Fetzer Company Roberts Digital VIPR System (with E-size cylinder)
Model: ROC-9840 Open, Classified |
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 | K142149 |
| 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 | K142149 |
| 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 | K142149 |
| 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 | K142149 |
| 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 | K142149 |
| Jul 20, 2015 | Western / Scott Fetzer Company Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package.
Product Usage:
Used to dispense Oxygen at prescribed flow rates to patients for therapeu Terminated |
CAN | None listed |
| Jun 23, 2014 | Western / Scott Fetzer Company Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) Terminated |
CAN | None listed |