Conserver, Oxygen

Device Code: 156

Product Code(s): NFB

Device Classification Information

• Device Type ID: 156
• Device Name: Conserver, Oxygen
• Regulation Description: Noncontinuous Ventilator (IPPB).
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Respiratory Devices Branch (RPDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5905 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NFB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 1-99 ASTM G175-13
  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

Total Product Life Cycle

• Device Type ID: 156
• Device: Conserver, Oxygen
• Product Code: NFB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Noncontinuous Ventilator (IPPB).
• CFR Regulation Number: 868.5905 [🔎]

Premarket Reviews
Manufacturer	Decision
SALTER LABS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	3
No Flow	2
Gas Leak	2
Fire	1
Device Operates Differently Than Expected	1
Flare Or Flash	1
Total Device Problems	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Invacare Corporation	II	Aug-08-2016

TPLC Last Update: 2019-04-02 19:29:51