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Device
nebulizer (direct patient interface)
Regulation Description
Nebulizer.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Product Code
CAF
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
868.5630
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Recognized Consensus Standards
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
1-173 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
Third Party Review
Not Third Party Eligible
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