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Device
conserver, oxygen
Regulation Description
Noncontinuous ventilator (IPPB).
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Product Code
NFB
Premarket Review
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type
510(k)
Regulation Number
868.5905
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
1-99 ASTM G175-13 (Reapproved 2021)
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
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
1-183 ASTM G175-24
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
Third Party Review
Eligible for
510(k) Third Party Review Program
Accredited Persons
beanstock consulting
global quality and regulatory services
regulatory technology services, llc
third party review group, llc
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