BEUDAMED
    5 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    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 (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

    FDA Enforcement
    Class II ·Ongoing·Western/Scott Fetzer Company·April 19, 2023

    Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

    FDA Enforcement
    Class II ·Ongoing·Western/Scott Fetzer Company·December 1, 2021

    Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603

    FDA Enforcement
    Class II ·Ongoing·Western/Scott Fetzer Company·December 1, 2021

    Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602

    FDA Enforcement
    Class II ·Ongoing·Western/Scott Fetzer Company·December 1, 2021

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Enforcement
    Class II ·Ongoing·DRE Medical Group Inc·July 5, 2023