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Device
ventilator, continuous, facility use
Regulation Description
Continuous ventilator.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Product Code
CBK
Premarket Review
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type
510(k)
Regulation Number
868.5895
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Ineligible
Implanted Device?
No
Life-Sustain/Support Device?
Yes
Recognized Consensus Standards
1-62 ISO 5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
1-129 ISO 5359 Fourth edition 2014-10-01
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]
1-130 ISO 18082 First edition 2014-06-15
Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]
1-134 ISO 18562-1 First edition 2017-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
1-135 ISO 18562-2 First edition 2017-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
1-136 ISO 18562-3 First edition 2017-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
1-137 ISO 18562-4 First edition 2017-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
1-138 ISO 80601-2-74 First edition 2017-05
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
1-146 ISO 80601-2-12 Second edition 2020-02
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
1-173 ISO 18562-1 Second edition 2024-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
1-174 ISO 18562-2 Second edition 2024-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
1-175 ISO 18562-3 Second Edition 2024-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
1-176 ISO 18562-4 Second Edition 2024-03
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
1-177 ISO 80601-2-74 Second edition 2021-07
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
Third Party Review
Not Third Party Eligible
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