ClearanceBrief
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

CodeDeviceRecords
ECXCylinder, Compressed Gas, And Valve7
CANRegulator, Pressure, Gas Cylinder6

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 17, 2015K142149OXYTOTE INFINITY SERIES VIPR SYSTEMS
Western/Scott Fetzer Co.
ECX

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 12, 2023Western/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
CANNone listed
Oct 16, 2021Western/Scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Open, Classified
CANNone listed
Oct 16, 2021Western/Scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Open, Classified
CANNone listed
Oct 16, 2021Western/Scott Fetzer Company
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Open, Classified
CANNone listed
Oct 16, 2021Western/Scott Fetzer Company
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
Open, Classified
ECXNone listed
Aug 15, 2019Western / 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
ECXK142149
Aug 15, 2019Western / 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
ECXK142149
Aug 15, 2019Western / 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
ECXK142149
Aug 15, 2019Western / 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
ECXK142149
Aug 15, 2019Western / 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
ECXK142149
Jul 20, 2015Western / 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
CANNone listed
Jun 23, 2014Western / Scott Fetzer Company
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Terminated
CANNone listed
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