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Medevac Use Oxygen Generator

Page Type
Product Code
Definition
A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW.
Physical State
oxygen concentrator, tubing, monitors and gauges, oxygen tank. This classification is only for oxygen generators that are used on MEDEVAC helicopters and are permanently affixed to the helicopter. For general use oxygen generators use product code CAW.
Technical Method
This device uses a molecular sieve (for example zeolite) or other means to concentrate oxygen for medical use. For general use portable oxygen generators, use product code CAW.
Target Area
This device is intended to provide oxygen for patients.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5440
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5440 Portable oxygen generator

§ 868.5440 Portable oxygen generator.

(a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

(b) Classification. Class II (performance standards).

Medevac Use Oxygen Generator

Page Type
Product Code
Definition
A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW.
Physical State
oxygen concentrator, tubing, monitors and gauges, oxygen tank. This classification is only for oxygen generators that are used on MEDEVAC helicopters and are permanently affixed to the helicopter. For general use oxygen generators use product code CAW.
Technical Method
This device uses a molecular sieve (for example zeolite) or other means to concentrate oxygen for medical use. For general use portable oxygen generators, use product code CAW.
Target Area
This device is intended to provide oxygen for patients.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5440
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5440 Portable oxygen generator

§ 868.5440 Portable oxygen generator.

(a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

(b) Classification. Class II (performance standards).