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Device
ventilator, non-continuous (respirator)
Regulation Description
Noncontinuous ventilator (IPPB).
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Product Code
BZD
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
1-62 ISO 5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
1-106 ISO 17510 First Edition 2015-08-01
Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
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
1-151 ISO 80601-2-70 Second edition 2020-11
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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
13-74 IEEE Std 11073-10424-2014
Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
13-94 ISO IEEE 11073-10424 First edition 2016-06-15
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
Guidance Document
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II
Third Party Review
Not Third Party Eligible
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