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Ventilators and Ventilator Accessories EUAs | FDA

    https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas
    Dec 16, 2022

Product Classification - Food and Drug Administration

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=193
    Product Classification. This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are …

Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    Classify Your Medical Device. The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped …

Product Classification - Food and Drug Administration

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=MNT
    Yes. Recognized Consensus Standards. 1-62 ISO 5356-1 Third edition 2004-05-15. Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and …



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